Externally applied intrapartum support device

ABSTRACT

The present disclosure describes a labor assistance system comprising a perianal support member and grip. The perianal support member includes a contact surface, an inner surface opposing the contact surface, and a rigid compression element. The contact surface has a generally continuous compression surface apex extending from the contact surface in a first direction, oriented to extend from an anterior edge to a posterior edge along a midline axis in a sagittal plane of the patient without substantially interfering with the birthing canal of the patient. The grip is coupled to the inner surface between the anterior edge and the posterior edge of the support member. The present disclosure also describes an intrapartum pelvic floor support device that is applied to tissue in the perianal and/or anococcygeal regions of the patient during an intrapartum period to support the anococcygeal region tissues and at least a portion of the pelvic floor.

PRIORITY DATA

This application is a continuation of U.S. application Ser. No.14/817,959 filed Aug. 4, 2015, which claims priority to and the benefitof the filing date of U.S. Patent Application No. 62/033,038 filed Aug.4, 2014, titled “Devices for Assisting the Progression of Labor DuringChildbirth”, and U.S. Patent Application No. 62/086,634 filed Dec. 2,2014, titled “Externally Applied Intrapartum Pelvic Floor SupportDevice”, each of which is incorporated herein by reference in theirentireties.

BACKGROUND

A typical labor process during childbirth is divided into three stages.The first and second stages are directly involved in the delivery of thechild, and the third stage involves the delivery of the placenta. Thefirst stage of labor begins with the onset of rhythmic uterinecontractions and ends with complete cervical dilatation. The secondstage of labor begins upon complete cervical dilatation and ends afterthe birth of the child. The third stage of labor extends from the birthof the child to the complete delivery of the placenta. The laborprogress, especially through the second stage of labor, is driven by twotypes of labor forces. The primary force is produced by the involuntarycontractions of the mother's uterus (i.e., uterine muscle contractions).The secondary force is produced by the increase of intra-abdominalpressure created by voluntary contractions of the mother's abdominalmuscles, including pelvic musculatures and diaphragm. These forces actsynergistically to increase the intrauterine pressure and aid theexpulsion of the child from the uterus.

The use of epidurals and pain relieving drugs during the labor anddelivery process can desensitize the birthing mother from experiencingthe natural body signals needed to push the baby through the birth canaland thereby ultimately delay the progression of childbirth. Oneindication of this phenomenon is that in recent years, there has been adramatic increase in the incidence of children born by Cesareanchildbirth. This form of child birth significantly increases the cost tothe healthcare system when compared to a natural vaginal delivery. Inaddition, the birthing mother needs significantly more time to recoverfrom a Cesarean operation compared to a natural vaginal child delivery.Systemic analgesic drugs, epidural anesthesia, and the long duration ofexhaustive labor all can lead to the weakening of the secondary force,and sequentially to delayed labor duration or even dystocia (arrest oflabor). Thus, in some instances, the duration of the second stage oflabor is prolonged by ineffective or inadequate pushing by the mother,which can lead to injuries of the pelvic floor, fetal distress, higherrate of infant mortality, neonatal seizures, postpartum hemorrhage,and/or to delivery by Cesarean section.

While prior apparatus and methods like those disclosed in U.S. PatentApplication Publications 2007/0031466 and U.S. Pat. No. 7,673,633provide stable support for the soft perianal tissues near the analorifice, these can be further improved to provide additional benefitsfor labor management to increase intrauterine pressure (e.g., bystrengthening contractions and pushing), thereby decreasing the durationof the second stage of labor and/or decreasing the incidence of Cesareanchildbirth. More specifically, there exists a need for devices thatpermit a healthcare provider to actively and intermittently monitor andguide the labor process to promote more effective fetal descent, therebydecreasing the duration of the second stage of labor and increasing thelikelihood of successful vaginal births.

The devices and methods described herein overcome one or moredeficiencies of the prior art.

SUMMARY

The present disclosure provides a device for assisting in theprogression of labor during childbirth. In one aspect, the deviceincludes a working end with a pressure surface or contact surfaceconfigured for spanning the anal orifice and a grip joined to theworking end. In one form, the device comprises a V-shaped contactsurface coupled to an elongate handle or grip. In a further form, theworking end includes an inner surface opposing the contact surface, andthe grip is coupled to the opposing inner surface. The grip can beattached to the working end at an adjustable angle by a pivotingassembly, at a fixed angle, or via a detachable connection.

In one embodiment, the working end includes compression membersextending outwardly from the contact surface. The compression membersextend equal lengths from the contact surface or may alternatively eachextend a different length from the contact surface. In one aspect, thecompression members each include a longer portion and a shorter portion.

In another embodiment, the working end comprises a V-shaped or U-shapedcontact surface. However, it will be appreciated that the working endcan include a flat contact surface. In one form, the working endincludes a transparent body and contact surface with the transparentbody and/or contact surface including markings. In one aspect, themarkings may assist a user in positioning the device on the patient. Inanother aspect, the markings may assist the user in measuring the tissuedistention against the contact surface through changing pressuresituations during labor. In a further form of the device, the workingend includes a transparent window extending through the contact surface.

In a further embodiment of the device, the working end includes a padcoupled to the contact surface. As set forth in the followingdescription, the pad is compliant and may be conformable to thepatient's body. In one aspect, the pad is adjustable to have a desiredturgidity or degree of conformability. In another aspect, the pad isinflatable with a variety of fluids to have a desired turgidity ordegree of conformability. The pad may be configured to retain its shapeafter the application of pressure.

In yet a further embodiment of a labor assist device, the working end ofthe device includes a focal protrusion extending outwardly from thecontact surface. In one aspect, the focal protrusion is positionedoff-center on the contact surface. In another aspect, the focalprotrusion may be configured for partial or complete insertion into theanal orifice of the patient.

In a further feature, the grip comprises a T-bar handle coupled to theinner surface of the working end. The T-bar handle can include aperturesconfigured to receive a user's fingers. In an alternative form, the gripcomprises a knob-like or tab-like handle. The tab-like handle caninclude an aperture or depression. In still a further form, the gripcomprises a tube-like passageway coupled to the inner surface of theworking end. In one aspect, the working end includes a channel thatextends from an anterior edge to a posterior edge of the device andaligns with the midline axis of the working end. In yet a further form,the grip comprises a curved support structure or compliant pad coupledto the inner surface of the working end.

In another aspect, the device includes a haptic feedback generator. Thehaptic feedback generator may be responsive to pressure applied to thecontact surface. In one form, the haptic feedback generator causesmovement of the working end, while in another, the haptic feedbackgenerator causes movement of the grip.

In still a further aspect, the device includes a push evaluation systemcoupled to the grip and including an apparatus configured to measure theextent of displacement of the contact surface from the second positionduring a push.

In a further feature, the present disclosure is directed to a laborassistance system for contact with external perianal tissue of a patientwith the system comprising a perianal support member and a grip. In oneaspect, the perianal support member includes a contact surface, an innersurface opposing the contact surface, and a rigid compression element.The contact surface may include a continuous compression surface apexextending from the contact surface in a first direction corresponding toa height of the apex. In one form, the contact surface is dimensioned tospan across an anal orifice without entering the anal canal forengagement with at least a portion of the external perianal tissue onopposing sides of the anal orifice of the patient. In a further form,the contact surface is oriented to extend from an anterior edge to aposterior edge along a midline axis in a sagittal plane of the patient,and the contact surface anatomically configured to not substantiallyinterfere with the birthing canal of the patient during childbirth. Therigid compression element has a proximal end portion and a distal endportion, with the compression element being operatively joined to thecontact surface adjacent the distal end portion and extending therefromin a second direction to the proximal end portion. In one form, thesecond direction is generally transverse to the midline axis. Thecompression element may be configured to transmit compressive forceapplied adjacent the proximal portion to the contact surface. In oneaspect, the grip is coupled to the inner surface between the anterioredge and the posterior edge. The grip can extend from the inner surfacein a third direction away from the contact surface. As described in moredetail in the following, the grip is shaped and configured for graspingby a user to position and hold the perianal support member against theperianal tissue of the patient.

In one embodiment, the present disclosure provides for a laborassistance system for contact with external perianal tissue of apatient, comprising a perianal support member including: a contactsurface, an inner surface opposing the contact surface, a compressionelement, and a grip. In one aspect, the contact surface has a continuouscompression surface apex extending from the contact surface in a firstdirection corresponding to a height of the apex, the contact surfacedimensioned to span across an anal orifice without entering the analcanal for engagement with at least a portion of the external perianaltissue on opposing sides of the anal orifice of the patient, the contactsurface oriented to extend from an anterior edge to a posterior edgealong a midline axis in a sagittal plane of the patient, the contactsurface anatomically configured to not substantially interfere with thebirthing canal of the patient during childbirth. In one aspect, thecompression element has a proximal end portion and a distal end portion,the compression element operatively joined to the contact surfaceadjacent the distal end portion and extending therefrom in a seconddirection to the proximal end portion, the second direction generallytransverse to the midline axis, the compression element configured totransmit compressive force applied adjacent the proximal portion to thecontact surface. In one aspect, the grip is coupled to the inner surfacebetween the anterior edge and the posterior edge and extending from theinner surface in a third direction away from the contact surface, andthe grip is shaped and configured for grasping by a user to position andhold the perianal support member against the perianal tissue of thepatient.

In one aspect, further including at least a second compression elementjoined to the contact surface. In one aspect, the second compressionelement extends in a fourth direction substantially transverse to themidline axis and at an angle with respect to the second direction. Inone aspect, the angle is between 130 and 30 degrees. In one aspect, theangle is between 100 and 70 degrees. In one aspect, the firstcompression element, the inner surface, and the second compressionelement meet to define an access cavity. In one aspect, the grip extendsthrough the access cavity between the first and second compressionelements. In one aspect, the grip extends from the inner surface at anoblique angle with respect to the midline axis. In one aspect, the gripextends from the inner surface at a transverse angle with respect to themidline axis.

In one aspect, the grip is coupled to the inner surface via a pivotelement. In one aspect, the grip extends from the inner surface at adynamic angle with respect to the midline axis. In one aspect, the pivotelement includes a locking feature configured to releasably lock thegrip at a fixed angle with respect to the midline axis. In one aspect,the pivot element is spaced a distance apart from the contact surface.In one aspect, the grip extends from the inner surface at a fixed anglewith respect to the midline axis.

In one aspect, the perianal support member includes a first heightextending from the proximal end portion of the compression element tothe apex, the grip includes a second height extending from a proximalend to a distal end of the grip, and the first height is less than thesecond height. In one aspect, the perianal support member includes afirst height extending from the proximal end portion of the compressionelement to the apex, the grip includes a second height extending from aproximal end to a distal end of the grip, and the first height isgreater than the second height.

In one aspect, the perianal support member includes a curved, convexcontact surface and a curved compression element having the same radiusof curvature as the contact surface. In one aspect, the perianal supportmember includes a substantially flat, planar contact surface.

In one aspect, the perianal support member includes a pressure elementdisposed on the contact surface, the pressure element extending from thecontact surface in the first direction. In one aspect, the pressureelement comprises a protrusion shaped and configured to apply a focalarea of increased pressure upon the external perianal tissue of thepatient. In one aspect, the pressure element is positioned on thecontact surface closer to the anterior edge than the posterior edge.

In one aspect, the contact surface includes a visual indicatorconfigured be aligned with a body reference marker to assist the user inpositioning the perianal support member against the patient.

In one aspect, the anterior edge of the perianal support member includesa concave portion alignable with the vaginal orifice of the patient.

In one aspect, the perianal support member includes a compliant paddisposed on the contact surface. In one aspect, the compliant padincludes a treating compound.

In one aspect, the grip comprises an elongated shaft terminating in acrossbar configured to form a grasping handle for the user. In oneaspect, the grip comprises an elongate shaft terminating at a knobconfigured to form a grasping handle for the user. In one aspect, thegrip comprises an elongate shaft terminating in a tab configured to forma grasping handle for the user. In one aspect, the tab forms an annularring. In one aspect, the grip comprises a hollow tube coupled to theinner surface and extending parallel to the midline axis. In one aspect,the grip comprises a channel formed within the perianal support member,the channel extending from the anterior edge to the posterior edge ofthe perianal support member. In one aspect, the grip comprises a curvedsupport structure including an upper surface having substantially thesame shape and contour as the inner surface of the perianal supportmember, the upper surface being in contact with the inner surface.

In one aspect, the system further comprises a push evaluation systemconfigured to measure the strength of the patient's pushes, the pushevaluation system including a spring-loaded device coupled to the grip.In one aspect, the spring-loaded device comprises a spring coupled tothe grip, a securing member extending from the spring and coupled to ananchor pad, the anchor pad including an adhesive portion configured toadhere to the patient.

In one aspect, the grip includes markings spaced relative to thesecuring member such that the position of the markings relative to thesecuring member indicates the degree of displacement of the perianalsupport device during a patient's push. In one aspect, the perianalsupport member is formed of a substantially clear material. In oneaspect, the perianal support member includes a plurality of measurementmarkers. In one aspect, the compression element includes a short portiondefining a posterior edge and a long portion defining an anterior edgeof the perianal support member.

In one aspect, at least a portion of the perianal support member isshaped and configured to conform to superficial contours of a pelvicfloor and apply pressure against an anococcygeal region of the patient.In one aspect, at least a portion of the perianal support member issufficiently rigid to apply pressure against an anococcygeal region ofthe patient.

The present disclosure is, at least in part, directed to a method ofproviding a laboring patient with a focal point against which to push.In one aspect, the method comprises providing a labor assistance systemhaving a perianal support member including a contact surface configuredfor engaging the pelvic floor area of the patient and a grip coupled tothe perianal support member and configured for a user to grasp. Themethod includes maneuvering the grip to position the contact surface ina first position in contact with skin adjacent the posterior pelvicfloor area of the patient. The method also includes applying pressurethrough the grip to the perianal support member to direct pressurethrough the contact surface against skin and into the pelvic floor areaof the patient, wherein applying pressure includes pushing the griptoward the patient during a uterine contraction and moving the contactsurface to a second position.

In one aspect, the method includes: providing a labor assistance systemhaving a pelvic floor support member including a contact surfaceconfigured for engaging the perianal area of the patient and;maneuvering the pelvic floor support member to position the contactsurface in a first position in contact with the perianal area of thepatient; and applying pressure to the pelvic floor support member todirect pressure through the contact surface against the perianal area ofthe patient during a uterine contraction.

In one aspect, the method further comprises maintaining the position ofthe pelvic floor support member against the perianal tissue throughoutthe duration of a uterine contraction. In one aspect, the method furthercomprises increasing the pressure applied through the contact surfaceagainst the perianal tissue as the uterine contraction gains strength.In one aspect, the method further comprises decreasing the pressureapplied through the contact surface against the perianal tissue as theuterine contraction loses strength. In one aspect, the method furthercomprises observing the strength of a push from the patient by measuringthe extent of displacement of the contact surface from the firstposition to a second position during a push.

In one aspect, the method further comprises a labor assistance systemincluding a push evaluation system coupled to the pelvic floor supportmember and including a spring-loaded device configured to measure theextent of displacement of the contact surface from the first position tothe second position during a push. In one aspect, wherein applyingpressure to the pelvic floor support member to direct pressure throughthe contact surface against the perianal area of the patient includespushing a grip coupled to the pelvic floor support member toward thepatient during a uterine contraction.

In still a further aspect, the present disclosure is directed to amethod of guiding a baby through a birth canal to a vaginal orificeduring childbirth. The method includes positioning a labor assistancesystem in contact with at least a portion of the skin overlying theposterior pelvic floor of the patient prior to delivery of the baby, andthe labor assistance system includes a grip extending from a perianalsupport member having a contact surface configured to engage theperianal tissue. In one aspect, the method includes positioning thecontact surface against at least a portion of perianal skin such thatthe contact surface operates as a sacral extension member and providesexternal scaffolding to support the anococcygeal region tissue and theposterior pelvic floor as well as to guide the baby through the birthcanal extending through the anterior pelvic floor. In another aspect,the method includes directing pressure through the grip toward thecontact surface against the perianal tissue in a direction configured toguide the baby toward the vaginal orifice.

In one aspect, the method includes: positioning a labor assistancesystem in contact with at least a portion of the anococcygeal region ofthe patient prior to delivery of the baby, the labor assistance systemincluding a perianal support member having a contact surface configuredto engage the anococcygeal region; positioning the contact surfaceagainst at least a portion of anococcygeal region such that the contactsurface operates as a sacral extension member and provides externalscaffolding to support at least a portion of the posterior pelvic floorto thereby guide the baby toward the birth canal; and directing pressurethrough the contact surface against the anococcygeal region in adirection configured to guide the baby toward the vaginal orifice.

In one aspect, the method further comprises changing the position of thecontact surface relative to the perianal tissue as the baby descendsthrough the birth canal. In one aspect, the method further compriseschanging the direction of pressure applied through the grip toward thecontact surface against the perianal tissue to guide the baby toward thevaginal orifice as the baby descends through the birth canal. In oneaspect, directing pressure through the contact surface against theanococcygeal tissue comprises directing pressure through a gripextending from the perianal support member toward the contact surface.

In a further embodiment, the present disclosure is directed to a methodof monitoring pressure in the pelvic tissues to assess the progressionof labor in a patient. The method includes positioning a laborassistance system in contact with at least a portion of the pelvictissues of the patient prior to delivery of a baby, and the laborassistance system includes a grip extending from a perianal supportmember having a contact surface configured to engage the pelvic tissue.In one aspect, the method includes positioning the contact surfaceagainst at least a portion of pelvic tissue such that pelvic tissueengages the contact surface across a first area. In a further aspect,the method includes observing the spread of the pelvic tissue across asecond area of the contact surface as the pressure changes against thecontact surface.

In one aspect, the method comprises: positioning a labor assistancesystem in contact with at least a portion of the perianal tissues of thepatient prior to delivery of a baby, the labor assistance systemincluding a grip extending from a perianal support member having acontact surface configured to engage the perianal tissue; positioningthe contact surface against at least a portion of perianal tissue suchthat perianal tissue engages the contact surface across a first area;and observing the spread of the perianal tissue across a second area ofthe contact surface as the pressure changes against the contact surface.In one aspect, the method further comprises comparing the first area tothe second area to measure the change in tissue distension as thepressure changes against the contact surface. In one aspect, the methodfurther comprises measuring the first area and the second area byobserving the engagement of perianal tissue with the contact surfacerelative to markings on the perianal support member.

The present disclosure also provides a non-invasive device forsupporting the pelvic floor during an intrapartum period. In one aspect,the device includes a central support element having a contact surfaceconfigured to be held against and extend from an anterior portionposterior to a vaginal opening of a patient to a posterior portion ofthe patient that is posterior to an anal orifice of the patient. A firstsupport element extends from the central support element in a firstlateral direction, the first support element comprising a first concaveinner surface to receive a first buttock of the patient and a firstconvex outer surface. A second support element extends from the centralsupport element in a second lateral direction opposite to the firstlateral direction, the second support element comprising a secondconcave inner surface to receive a second buttock of the patient and asecond convex outer surface. The non-invasive intrapartum pelvic floorsupport device is held against superficial tissue superior to the pelvicfloor of the patient to support the pelvic floor during an intrapartumperiod of the patient. In one aspect, the device comprises a centralsupport element having a contact surface configured to be held againstand extend from an anterior portion posterior to a vaginal opening of apatient to a posterior portion of the patient that is posterior to ananal orifice of the patient; a first support element extending from thecentral support element in a first lateral direction, the first supportelement comprising a first concave inner surface to receive a firstbuttock of the patient; and a second support element extending from thecentral support element in a second lateral direction opposite to thefirst lateral direction, the second support element comprising a secondconcave inner surface to receive a second buttock of the patient,wherein the non-invasive intrapartum pelvic floor support device is heldagainst tissue superficial to the pelvic floor of the patient to supportthe pelvic floor during an intrapartum period of the patient.

In one aspect, the non-invasive intrapartum pelvic floor support deviceis held against the tissue superficial to the pelvic floor with anadhesive between an inner surface of the non-invasive intrapartum pelvicfloor support device and skin of the patient. In one aspect, the innersurface comprises the first and second concave inner surfaces.

In another embodiment, the non-invasive intrapartum pelvic floor supportdevice includes a central support element having a contact surfaceconfigured to be held against and extend from an anterior portionposterior to a vaginal opening of a patient to a posterior portion ofthe patient that is posterior to an anal orifice of the patient, thecentral support element comprising a concave inner surface facing thepatient and a convex outer surface. A first support element extends fromthe central support element in a first lateral direction. A secondsupport element extends from the central support element in a secondlateral direction opposite to the first lateral direction. Thenon-invasive intrapartum pelvic floor support device is held againstsuperficial tissue superior to the pelvic floor of the patient tosupport the pelvic floor during an intrapartum period of the patient.

In one aspect, the device comprises a central support element having acontact surface configured to be held against and extend from ananterior portion posterior to a vaginal opening of a patient to aposterior portion of the patient that is posterior to an anal orifice ofthe patient, the central support element comprising a concave innersurface facing the patient and a convex outer surface; a first supportelement extending from the central support element in a first lateraldirection; and a second support element extending from the centralsupport element in a second lateral direction opposite to the firstlateral direction, wherein the non-invasive intrapartum pelvic floorsupport device is held against tissue superficial to the pelvic floor ofthe patient to support the pelvic floor during an intrapartum period ofthe patient.

In one aspect, an anterior portion of the first support element and ananterior portion of the second support element extend in an anteriordirection beyond an anterior portion of the central support element todefine a recess at the central support element to allow access to thevaginal opening.

In one aspect, a lateral width of the central support element variesalong the contact surface between an anterior portion and a posteriorportion of the non-invasive intrapartum pelvic floor support device.

In another embodiment, a support system includes the non-invasiveintrapartum pelvic floor support device comprising a central supportelement having a contact surface configured to be held against andextend from an anterior portion posterior to a vaginal opening of apatient to a posterior portion of the patient that is posterior to ananal orifice of the patient along a midline axis in a sagittal plane ofthe patient. The non-invasive intrapartum pelvic floor support devicealso includes a first support element extending from the central supportelement in a first lateral direction and a second support elementextending from the central support element in a second lateral directionopposite to the first lateral direction. The support system alsoincludes a perianal support member including a contact surfacedimensioned to span across an anal orifice without entering an analcanal for engagement with at least a portion of external perianal tissueon opposing sides of the anal orifice of the patient, the contactsurface oriented to extend from an anterior edge to a posterior edgealong a midline axis in a sagittal plane of the patient. An innersurface of the perianal support member opposes the contact surface. Acompression element of the perianal support member has a proximal endportion and a distal end portion, the compression element operativelyjoined to the contact surface adjacent the distal end portion andextending therefrom in a second direction to the proximal end portion,the second direction generally transverse to the midline axis, thecompression element configured to transmit compressive force appliedadjacent the proximal portion to the contact surface. The non-invasiveintrapartum pelvic floor support is configured to receive the perianalsupport member along the midline axis during an intrapartum period ofthe patient.

In one aspect, the support system comprises a non-invasive intrapartumpelvic floor support comprising: a central support element having acontact surface configured to be held against and extend from ananterior portion posterior to a vaginal opening of a patient to aposterior portion of the patient that is posterior to an anal orifice ofthe patient along a midline axis in a sagittal plane of the patient; afirst support element extending from the central support element in afirst lateral direction; and a second support element extending from thecentral support element in a second lateral direction opposite to thefirst lateral direction; and a perianal support member. In one aspect,the perianal support member includes a contact surface dimensioned tospan across an anal orifice without entering an anal canal forengagement with at least a portion of external perianal tissue onopposing sides of the anal orifice of the patient, the contact surfaceoriented to extend from an anterior edge to a posterior edge along amidline axis in a sagittal plane of the patient; an inner surfaceopposing the contact surface; and a compression element having aproximal end portion and a distal end portion, the compression elementoperatively joined to the contact surface adjacent the distal endportion and extending therefrom in a second direction to the proximalend portion, the second direction generally transverse to the midlineaxis, the compression element configured to transmit compressive forceapplied adjacent the proximal portion to the contact surface. In oneaspect, the non-invasive intrapartum pelvic floor support is configuredto receive the perianal support member along the midline axis during anintrapartum period of the patient.

In one aspect, the non-invasive intrapartum pelvic floor support furthercomprises a gap along the central support element and a first part of alocking mechanism, and the perianal support member further comprises asecond part of the locking mechanism, the second part being configuredto couple with the first part to operatively join the non-invasiveintrapartum pelvic floor support and the perianal support membertogether.

In one aspect, the perianal support member further comprises anadjustable strap connected between the compression element of theperianal support member an anchor mechanism, the strap configured toincrease or decrease pressure to the external perianal tissue inresponse to tightening or loosening of the strap.

In another embodiment, the non-invasive intrapartum pelvic floor supportdevice includes a flexible anterior support structure having a firstrigidity for supporting a pelvic floor of a patient, the flexibleanterior support structure extending along a midline axis of the patientfrom an anterior portion that is posterior to a vaginal opening of thepatient to a posterior portion of the patient that is posterior to ananal orifice of the patient, and in a first lateral direction toward afirst buttocks of the patient and a second lateral direction toward asecond buttocks of the patient. The non-invasive intrapartum pelvicfloor support device also includes a first lateral support structureextending from the flexible anterior support structure around a lateralside of the first buttocks, and a second lateral support structureextending from the flexible anterior support structure around a lateralside of the second buttocks, the first and second lateral supportstructures having a second rigidity that is less than the firstrigidity. The first and second lateral support structures are configuredto transfer a load from the flexible anterior support structure.

In one aspect the device comprises: a flexible anterior supportstructure having a first rigidity for supporting a pelvic floor of apatient, the flexible anterior support structure extending along amidline axis of the patient from an anterior portion that is posteriorto a vaginal opening of the patient to a posterior portion of thepatient that is posterior to an anal orifice of the patient, and in afirst lateral direction toward a first buttocks of the patient and asecond lateral direction toward a second buttocks of the patient; afirst lateral support structure extending from the flexible anteriorsupport structure around a lateral side of the first buttocks; and asecond lateral support structure extending from the flexible anteriorsupport structure around a lateral side of the second buttocks, thefirst and second lateral support structures having a second rigiditythat is less than the first rigidity, wherein the first and secondlateral support structures are configured to transfer a load from theflexible anterior support structure.

In one aspect, the flexible anterior support structure comprises a firstmesh, the first and second lateral support structures comprise a secondmesh, and the first mesh has a higher rigidity than the second mesh. Inone aspect, the non-invasive intrapartum pelvic floor support devicecomprises a material sheet, the flexible anterior support structurecomprises a first plurality of ridges along a first portion of thematerial sheet, and the first and second lateral support structurescomprise a second plurality of ridges along a second portion of thematerial sheet. In one aspect, at least a portion of an interior portionof the non-invasive intrapartum pelvic floor support device facing thepatient comprises an adhesive to adhere the between an inner surface ofthe non-invasive intrapartum pelvic floor support device and skin of thepatient to skin of the patient.

In another embodiment, the non-invasive intrapartum pelvic floor supportdevice includes a first contact member configured to attach to a lateralportion of a first buttock of a patient near a first crown of the firstbuttock. A second contact member is configured to attach to a lateralportion of a second buttock of the patient near a second crown of thesecond buttock. A joining member is configured to join between the firstand second contact members and pull the first and second buttockslaterally inward toward each other to support a pelvic floor of thepatient.

In one aspect, the device comprises: a first contact member configuredto attach to a lateral portion of a first buttock of a patient near afirst crown of the first buttock; a second contact member configured toattach to a lateral portion of a second buttock of the patient near asecond crown of the second buttock; and a joining member configured tojoin between the first and second contact members and pull the first andsecond buttocks laterally inward toward each other to support tissuesuperficial to a pelvic floor of the patient. In one aspect, the joiningmember comprises a flexible strap attached between the first and secondcontact members, the first contact member comprises a first adhesiveanchor pad configured to releasably adhere to the lateral portion of thefirst buttock, and the second contact member comprises a second adhesiveanchor pad configured to releasably adhere to the lateral portion of thesecond buttock. In one aspect, the flexible strap comprises an arcuateshape that is concave at an anterior portion and convex at a posteriorportion to allow access to a vaginal opening of the patient. In oneaspect, the joining member comprises an inflatable support deviceconfigured to inflate with a fluid, the inflatable support devicecomprising the first and second contact members to contact the lateralportions of the first and second buttocks upon at least partialinflation with the fluid.

Further aspects, forms, embodiments, objects, features, benefits, andadvantages of the present disclosure shall become apparent from thedetailed drawings and descriptions provided herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of an exemplary labor assistance systemapplied to a patient with stylized depiction of the patient anatomyaccording to one embodiment of the present disclosure.

FIG. 2A illustrates a partial perspective bottom view of the laborassistance system shown in FIG. 1 applied to a patient during childdelivery. FIGS. 2B and 2C illustrate partial perspective bottom views ofan exemplary labor assistance system positioned against a patient duringtwo different pressure situations during child delivery. In addition,FIG. 2C illustrates exemplary securing members according to oneembodiment of the present disclosure.

FIG. 3 illustrates a perspective view of the labor assistance systemshown in FIG. 1 according to one embodiment of the present disclosure.

FIG. 4 illustrates a side view of the labor assistance system shown inFIG. 1 according to one embodiment of the present disclosure.

FIG. 5A illustrates a perspective side view of an exemplary laborassistance system according to one embodiment of the present disclosure.

FIG. 5B illustrates a cutaway side view of the exemplary laborassistance system shown in FIG. 5A according to one embodiment of thepresent disclosure.

FIG. 6 illustrates a perspective view of an exemplary perianal supportmember according to one embodiment of the present disclosure.

FIG. 7 illustrates a perspective view of an exemplary perianal supportmember according to one embodiment of the present disclosure.

FIG. 8 illustrates a perspective view of an exemplary perianal supportmember according to one embodiment of the present disclosure

FIG. 9A illustrates a perspective view of an exemplary perianal supportmember according to one embodiment of the present disclosure.

FIG. 9B illustrates a perspective view of the exemplary perianal supportmember shown in FIG. 9A including exemplary securing members accordingto one embodiment of the present disclosure.

FIG. 10 illustrates an exemplary labor assistance system including theperianal support member shown in FIG. 1 coupled to an exemplary gripaccording to one embodiment of the present disclosure.

FIG. 11 illustrates an exemplary labor assistance system including theperianal support member shown in FIG. 1 coupled to an exemplary gripaccording to one embodiment of the present disclosure.

FIG. 12 illustrates an exemplary labor assistance system including theperianal support member shown in FIG. 1 coupled to an exemplary gripaccording to one embodiment of the present disclosure.

FIG. 13 illustrates an exemplary labor assistance system including theperianal support member shown in FIG. 1 coupled to an exemplary gripaccording to one embodiment of the present disclosure.

FIG. 14 illustrates an exemplary labor assistance system including theperianal support member shown in FIG. 1 coupled to an exemplary gripaccording to one embodiment of the present disclosure.

FIG. 15 illustrates an exemplary labor assistance system including anexemplary push evaluation system positioned on the patient 10 accordingto one embodiment of the present disclosure.

FIG. 16A illustrates a cross-sectional view of a patient in the sagittalplane and the labor assistance system taken along the lines 16-16 shownin FIG. 2.

FIG. 16B illustrates a similar cross-sectional view of a patient in thesagittal plane and the exemplary labor assistance system shown in FIG.9A.

FIG. 17 illustrates a flow chart illustrating a method of utilizing anexemplary labor assistance system according to one aspect of the presentdisclosure.

FIG. 18 illustrates an exemplary childbirth assisting system accordingto one embodiment of the present disclosure.

FIG. 19 illustrates an exemplary abdominal girdle according to oneembodiment of the present disclosure.

FIG. 20 illustrates an exemplary abdominal girdle according to oneembodiment of the present disclosure.

FIG. 21 illustrates a cross-sectional view of a patient in the sagittalplane, an exemplary labor assistance system, and an exemplary childbirthassisting system according to one embodiment of the present disclosure.

FIG. 22A illustrates a perspective view of an exemplary labor assistancesystem including an exemplary perianal support member according to oneembodiment of the present disclosure.

FIG. 22B illustrates a side view of the exemplary labor assistancesystem shown in shown in FIG. 22A according to one embodiment of thepresent disclosure.

FIG. 22C illustrates a top view of the exemplary labor assistance systemshown in FIG. 22B including exemplary securing members according to oneembodiment of the present disclosure.

FIG. 23 illustrates a partial perspective bottom view of the laborassistance system shown in FIG. 22A applied to a patient during childdelivery.

FIG. 24 illustrates a cross-sectional view of a patient in the sagittalplane, and includes the labor assistance system shown in FIG. 22Apositioned on a patient.

FIG. 25 illustrates is a partial cross sectional bottom view andstylized depiction of a patient anatomy.

FIG. 26A illustrates a bottom view of an exemplary intrapartumanococcygeal support device positioned on a patient according to oneembodiment of the present disclosure with stylized depiction of apatient anatomy.

FIG. 26B illustrates a top view of the exemplary intrapartumanococcygeal support device patient shown in FIG. 26A according to oneembodiment of the present disclosure.

FIG. 26C illustrates a perspective view of the exemplary intrapartumanococcygeal support device patient shown in FIG. 26A according to oneembodiment of the present disclosure.

FIG. 26D illustrates a side view of the exemplary intrapartumanococcygeal support device patient shown in FIG. 26A according to oneembodiment of the present disclosure.

FIG. 27 illustrates a rear view of the intrapartum anococcygeal supportdevice shown in FIGS. 26A-27D positioned on a patient according to anembodiment of the present disclosure.

FIG. 28 illustrates a perspective view of an exemplary intrapartumanococcygeal support device positioned on a patient according to oneembodiment of the present disclosure.

FIG. 29 illustrates a bottom view of the intrapartum anococcygealsupport device shown in FIG. 28 positioned on a patient according to oneembodiment of the present disclosure.

FIG. 30 illustrates a bottom view of an exemplary intrapartumanococcygeal support device positioned on a patient according to oneembodiment of the present disclosure.

FIG. 31A illustrates an exemplary intrapartum anococcygeal supportdevice and an exemplary perianal support member positioned on a patientaccording to an embodiment of the present disclosure.

FIG. 31B illustrates an exemplary locking mechanism for an intrapartumanococcygeal support device and a perianal support member according toan embodiment of the present disclosure

FIG. 32A illustrates an intrapartum pelvic floor support devicepositioned on a patient according to an embodiment of the presentdisclosure.

FIG. 32B illustrates a partial perspective top view of an intrapartumpelvic floor support device according to an embodiment of the presentdisclosure.

FIG. 32C illustrates a side view of an intrapartum pelvic floor supportdevice according to an embodiment of the present disclosure.

FIG. 33 illustrates an intrapartum pelvic floor support device accordingto an embodiment of the present disclosure.

FIG. 34A illustrates an intrapartum pelvic floor support deviceaccording to an embodiment of the present disclosure.

FIG. 34B illustrates an intrapartum pelvic floor support deviceaccording to an embodiment of the present disclosure.

FIG. 34C illustrates an intrapartum pelvic floor support deviceaccording to an embodiment of the present disclosure.

FIG. 34D illustrates an intrapartum pelvic floor support deviceaccording to an embodiment of the present disclosure.

FIG. 35 illustrates an intrapartum pelvic floor support devicepositioned on a patient according to an embodiment of the presentdisclosure.

FIG. 36 illustrates an intrapartum pelvic floor support devicepositioned on a patient according to an embodiment of the presentdisclosure.

FIG. 37A illustrates a bottom view of an intrapartum pelvic floorsupport device positioned on a patient according to an embodiment of thepresent disclosure.

FIG. 37B illustrates a bottom view of an intrapartum pelvic floorsupport device positioned on a patient according to an embodiment of thepresent disclosure.

FIG. 37C illustrates a bottom view of an intrapartum pelvic floorsupport device positioned on a patient according to an embodiment of thepresent disclosure.

FIG. 37D illustrates a perspective view of an intrapartum pelvic floorsupport device shown in FIG. 37C according to an embodiment of thepresent disclosure.

FIG. 37E illustrates a side view of an intrapartum pelvic floor supportdevice shown in FIG. 37C according to an embodiment of the presentdisclosure.

FIG. 38 illustrates an intrapartum pelvic floor support devicepositioned on a patient according to an embodiment of the presentdisclosure.

FIG. 39 illustrates an intrapartum pelvic floor support devicepositioned on a patient according to an embodiment of the presentdisclosure.

FIG. 40 illustrates an intrapartum pelvic floor support device accordingto an embodiment of the present disclosure.

FIG. 41 illustrates an intrapartum pelvic floor support devicepositioned on a patient according to an embodiment of the presentdisclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the disclosure is intended. In the following detaileddescription of the aspects of the invention, numerous specific detailsare set forth in order to provide a thorough understanding of thedisclosed embodiments. However, it will be obvious to one skilled in theart that the embodiments of this disclosure may be practiced withoutthese specific details. In other instances well known methods,procedures, components, and circuits have not been described in detailso as not to unnecessarily obscure aspects of the embodiments of theinvention. The following patents and patent applications areincorporated by reference.

U.S. Pat. No. 8,123,760, filed Aug. 5, 2005, titled “Method, Apparatusand System for Preventing or Reducing the Severity of Hemorrhoids,” andcommonly assigned to the present applicant, is hereby incorporated byreference in its entirety.

U.S. patent application Ser. No. 11/743,858, filed Aug. May 3, 2007,issued as U.S. Pat. No. 7,673,633, entitled “Apparatus and Method ofInhibiting Perianal Tissue Damage,” and commonly assigned to the presentapplicant, is hereby incorporated by reference in its entirety.

U.S. patent application Ser. No. 12/106,956, filed Aug. Apr. 21, 2008,and published as Patent Application Publication No. 2008/0202505,entitled “Apparatus and Method of Supporting Patient Tissue,” andcommonly assigned to the present applicant, is hereby incorporated byreference in its entirety.

U.S. Pat. No. 8,684,954, filed Mar. 15, 2013, entitled “Labor ManagementDevices for Decreasing the Incidence of Cesarean Childbirth,” andcommonly assigned to the present applicant, is hereby incorporated byreference in its entirety.

U.S. Pat. No. 5,871,499, filed Apr. 25, 1997, titled “Child BirthAssisting System,” and assigned to Novatrix, Inc., is herebyincorporated by reference in its entirety.

Any alterations and further modifications to the described devices,instruments, methods, and any further application of the principles ofthe present disclosure are fully contemplated as would normally occur toone skilled in the art to which the disclosure relates. In particular,it is fully contemplated that the features, components, and/or stepsdescribed with respect to one embodiment may be combined with thefeatures, components, and/or steps described with respect to otherembodiments of the present disclosure. In addition, dimensions providedherein are for specific examples and it is contemplated that differentsizes, dimensions, and/or ratios may be utilized to implement theconcepts of the present disclosure. To avoid needless descriptiverepetition, one or more components or actions described in accordancewith one illustrative embodiment can be used or omitted as applicablefrom other illustrative embodiments. For the sake of brevity, thenumerous iterations of these combinations will not be describedseparately. For simplicity, in some instances the same reference numbersare used throughout the drawings to refer to the same or like parts.

The present disclosure is directed to systems, devices, and methods formonitoring and assisting the progression of labor during childbirth byproviding a qualitative pressure indicator while supporting and/ortreating the perianal and anococcygeal tissues of a patient. These laborassistance systems introduce novel elements and methods that may assistthe management, progress, and effectiveness of labor along withsupporting and/or treating the tissues, muscles, and organs of thepelvic region, including, by way of non-limiting example, the pelvictissues, muscles, and organs within the anogenital triangle and the analtriangle (e.g., the pelvic diaphragm, the coccygeus muscle and thelevator plate), the perianal region, the perineal region, and theanococcygeal region. The embodiments may provide visual and/or tactilefeedback to healthcare providers and patients regarding changes inpressure levels due to device application or physiologicaltransformations, such as those that occur with uterine contractions orvoluntary contractions during child delivery (including, by way ofnon-limiting example, changes in uterine, pelvic, rectal, anal,perianal, intrauterine, intrapelvic, intrarectal, and/or intra-analpressures). Application of pressure in the perianal and anococcygealregions can be sensed as a tactile sensation by a patient, often evenafter administration of an epidural and provides a pushing focal pointto enhance the effectiveness of contractions. For example, in someinstances, the embodiments disclosed herein provide a tactile (andsometimes visual) focal point at the perianal region on which thepatient can focus her pushing effort during voluntary musclecontractions. The embodiments described herein provide a qualitativesense to the user and/or the patient of the relative amount of pressurethat is being applied to the device by the patient's tissue and/or therelative amount of pressure that is being applied to the patient by thedevice. Thus, the devices described herein provide an indication (e.g.,a tactile, haptic, and/or visual indication) in real time of the changein pressure relationships between the device and the patient as thepatient's labor progresses.

In addition, some embodiments may increase the intensity and/or numberof intrauterine contractions, thereby shortening the second stage oflabor and decreasing the occurrence of various negative effects of aprolonged labor (e.g., injuries of the pelvic floor, fetal distress,higher rate of infant mortality, neonatal seizures, postpartumhemorrhage, and/or to delivery by Cesarean section). In some instances,the embodiments disclosed herein may apply sufficient pressure to theperianal region to stimulate the patient's physiologic urge to push(e.g., similar to the Ferguson reflex, which triggers uterinecontractions). These effects may result in a shortening of the secondstage of labor by enhancing the effectiveness of contractions (e.g., byincreasing the intensity and or number of contractions) in advancing thebaby down the birth canal.

In some instances, the labor assistance systems disclosed herein may beused to support the perianal tissue and/or anococcygeal region of apatient during the second stage of labor, which may reduce the incidenceof a number of complications and conditions, including, for example,pelvic floor incompetence or dysfunction (over-stretching of pelvicfloor muscles, ligaments and tendons), organ prolapse results from theover stretching, incontinence secondary to pressure and stretchingexerted on bladder and bladder neck, over-stretching due to use offorceps in delivery, perineum tears and lacerations due to overstretching, vacuum or forceps use, uncontrolled flexion/extension of thefetal head as it descends, and hemorrhoids. The pelvic floor, sometimesreferred to as the pelvic diaphragm, is the inferior border of thepelvic cavity defined between the lower openings of the pelvic girdle.The pelvic floor has two hiatuses (gaps or openings): the anteriorurogenital hiatus through which the urethra and vagina pass and theposterior rectal hiatus through which the anal canal passes. The pelvicfloor facilitates birth by resisting the descent of the presenting partof the baby (i.e., typically the head of the baby), causing the baby torotate forward to navigate through the pelvic girdle and exit throughthe vaginal opening in the anterior urogenital hiatus in the pelvicfloor (see, for example, FIG. 16A). In particular, the pelvic floor, thesacrum, and the coccyx provide resistance against the downward descentof the baby (along the longitudinal axis of the baby and toward theposterior rectal hiatus) caused by force of the mother's uterinecontractions. This passive resistance causes the baby's head to rotateand descend in the direction of least resistance, which is usually inthe direction of the midline of the maternal pelvis.

In one aspect, an external labor assist device is provided to applypressure to and push against the skin of the anococcygeal and/orperianal tissues outside the pelvic floor to thereby support theinternal pelvic floor tissues in their function of guiding the babytoward the vaginal opening. Support of the posterior pelvic floor by thedevices disclosed herein facilitates the progression of the baby throughthe birth canal toward the vaginal opening by acting as a type ofexternal scaffolding to lengthen the path of passive resistance thatturns and guides the baby towards the vaginal opening. In someinstances, the pelvic floor and anococcygeal support provided by thedevices disclosed herein facilitate the delivery of the baby with feweruterine and voluntary contractions for the mother, thereby reducing theoverall length of the second stage of labor and reducing injury to themother (e.g., from the distention of pelvic floor and anal tissues thatresult from force applied by the baby in the direction of the posteriorrectal hiatus).

In some instances, the embodiments disclosed herein provide externalbirth canal support devices that may be manually repositioned throughoutthe labor process to effectively channel the mother's pushing forcealong the appropriate axis to guide the child's head through a desirableexit path from the birth canal. In some instances, the embodimentsdisclosed herein may cover all or most of the anal orifice, and therebyprovide defecation suppression, hemorrhoid development, and/or theadvancement of existing hemorrhoids. In some instances, the embodimentsdisclosed herein enhance the willingness of the patient to push wheninstructed by lessening the patient's fear of trauma and/or involuntarydefecation as a result of pushing.

The labor assistance systems disclosed herein can efficiently,effectively, removably, and safely prevent prolonged duration of laborand dystocia due to various causes, including, without limitation,systemic analgesia, epidural anesthesia, and/or maternal exhaustion,which may avoid a Cesarean section and/or an instrument-assisteddelivery. Given that weakening of the secondary labor force has beenreported in patients receiving epidural anesthesia, the systems mayeffectively enable a safer and less painful delivery under anesthesia bypreventing weakening of the secondary labor force (e.g., even underanesthesia). Thus, the labor assistance systems disclosed herein mayreduce the necessity of Cesarean section deliveries and/orinstrument-assisted deliveries by guiding the patient and monitoring(via pressure feedback) the strength and focus of contractions togenerate a more effective pushing effect on the baby. By reinforcing thesecondary labor force, the labor assistance systems disclosed herein maylower the dosage of oxytocin (or other pharmacological contractionaides) necessary during labor. In some instances, the systems disclosedherein may be used to cooperatively complement the effects of oxytocinduring labor.

Turning now to FIG. 1-4, a labor assistance system 100 according to oneexemplary embodiment disclosed herein is illustrated. FIGS. 1 and 2 showthe labor assistance system 100 in association with the perianal tissueof a patient 10, and FIGS. 3 and 4 show the labor assistance system 100independent of the patient 10.

In FIG. 1, the patient 10 is shown in partial cross section toillustrate a portion of the rectum 54, anal canal 36, anal orifice 26,internal venous plexus 29, pectinate line 37 (also known as the dentateline), and external venous plexus 28. The patient's buttocks 14 and 15are shown with the crowns of the buttocks 16 and 17, respectively,laterally adjacent the perianal region 38. The gluteal cleft 13 (FIG. 2)is between the buttocks 14 and 15. The buttocks 14 and 15 extendlaterally beyond crowns 16 and 17 toward lateral flanks 18 and 19,respectively. The crowns 16 and 17 of each buttocks 14 and 15 in essencedefine the midline of each leg and the lateral flanks 18 and 19 are thearea lateral of the leg/buttocks midline. The lateral flanks 18 and 19may include, for example but without limitation, all or a portion of thelateral buttocks, hips, or upper thigh of the patient.

FIG. 2 illustrates the patient 10 during a child birthing process.Contractions during labor move a child 12 into the birth canal andultimately, for a vaginal delivery, through the vaginal opening 11, asshown in FIG. 2. In an alternative birthing process, labor is commencedto move the child 12, but for a variety of reasons, the delivery doesnot occur vaginally but instead caesarian delivery is performed througha surgical opening in the mother's abdomen. During the birthing process,tremendous pressure is exerted (e.g., generated by voluntary andinvoluntary muscle contractions) in an effort to move the child 12toward delivery through the vaginal opening 11. By applying counterpressure with the labor assistance system 100 in the opposite directionto the perianal region 38 and the anal orifice 26 (FIG. 1), a user(e.g., a healthcare practitioner or the patient 10) can provide thepatient 10 with a tactile, discrete source of resistance against whichto push and support pelvic floor tissues to direct forces applied to thebaby toward the vaginal opening.

In some embodiments, as described further below in relation to FIG. 15,the labor assistance systems disclosed herein can provide indicatorsthat detect changes in intrauterine pressure or pelvic tissue distension(e.g., by way of non-limiting example, anal distension, pelvic floordistension, perineal distension), and/or indicate when desiredapplication pressures are achieved. Some exemplary embodiments providefeedback to users regarding changes in relevant pressure levels due todevice application or physiological transformations, such as those thatoccur during muscle contractions during child delivery. The embodimentsdisclosed herein allow for real-time user adjustment systems andtechniques, allowing a patient as well as a doctor to adjust the devicefor maximum comfort and effectiveness.

At least some of the pressure generated during labor is exerted againstthe tissues of the pelvic floor adjacent the anal orifice 26 in theperianal region 38 (FIG. 1). The result of these forces is that bloodvessels near the anus, such as those in the external venous plexus 28,may bulge or rupture causing hemorrhoids or increasing their severity.Still further, other tissues in the perianal region 38 adjacent the anusmay distend outwardly opposite arrow A4 in FIG. 1 causing lacerationssuch as tearing around the vaginal opening 11 or fissures from the anus.In addition to the blood loss, pain, and discomfort, these lacerationscan be a location for infections in the mother. The systems, devices,and methods disclosed herein, including the exemplary labor assistancesystem 100, are shaped and structured to not only increase the strengthand/or number of contractions by providing a tactile and/or visual guideto the mother during the birthing process, but also include features,elements, or structure that support the perianal tissues (tissue formingor supporting the perianal region 38) without interfering with thebirthing canal or vaginal opening 11. For example, the exemplarysystems, devices, and methods disclosed herein may support the tissue ofthe pelvic floor to inhibit damage to the tissue near the anal orifice26, both internally and externally, to inhibit, for example but withoutlimitation, the formation or advancement of external hemorrhoids, and/orto inhibit the formation or advancement of lacerations of the perianaltissues.

As shown in FIGS. 1 and 2, the labor assistance system 100 includes aperianal support member 102 having an external pressure surface orcontact surface 104 and a grip 106. The contact surface 104 includes acontinuous compression surface apex 105 dimensioned to span across ananal orifice for engagement with at least a portion of the externalperianal tissue on opposing sides of the anal orifice of the patient.The contact surface 104 is anatomically configured to not enter the analcanal. For example, the contact surface 104 in the pictured embodimentcomprises a convex, curved surface having a radius of curvature sized tosubstantially prevent the apex from entering the anal canal of thepatient. The contact surface, and in particular the compression surfaceapex 105, is oriented to extend along a first direction in a sagittalplane of the patient when the system 100 is positioned within thegluteal cleft 13. As shown in FIG. 2, the contact surface 104 extendsalong a midline axis 108 extending longitudinally between a posterioredge 110 and an anterior edge 112 of the perianal support member. Thegrip 106 is configured to assist a user in holding the perianal supportmember 102 in pressurized engagement with the perianal tissue in theperianal region 38. In the pictured embodiment, the grip 106 isconfigured as a handle.

FIG. 3 shows a perspective view of the labor assistance system 100independent of the patient 10, and FIG. 4 shows a side view of the laborassistance system 100 independent of the patient 10. The perianalsupport member 102 includes a pair of compression elements 116, 124extending laterally from the contact surface 104. In the picturedembodiment, the compression elements 116, 124 are formed as flangesextending laterally from the contact surface 104. The first compressionelement 116 has a distal end portion 118 adjacent the contact surface104 and an opposing proximal end portion 120. The opposing secondcompression element 124 has a distal end portion 126 adjacent thecontact surface 104 and an opposing proximal end portion 128. Theperianal support member 102 includes an outer surface 130 and anopposing inner surface 132 defining an access cavity 136.

In the pictured embodiment, the grip 106 extends from an area of theinner surface 132 located opposite the contact surface 104 (e.g., aninternal contact surface 143). The grip 106 extends from the internalcontact surface 143 in a direction away from the contact surface 104. Inthe pictured embodiment, the grip is spaced substantially equidistantfrom the anterior edge 112 and the posterior edge 110. In otherembodiments, the grip 106 may be spaced closer to the anterior edge 112or the posterior edge 110. In other embodiments, as described below withreference to FIGS. 10-14, the grip 106 may be formed in a variety ofother shapes and coupled to the inner surface 132 in a variety ofdifferent ways. In the pictured embodiment, the grip 106 extends fromthe inner surface 132 at a constant angle relative to the midline axis108 along an axis 134, which lies substantially perpendicular to themidline axis 108. It can be understood that the contact surface 104 isconfigured to be positioned at the gluteal cleft of the patient 10 withthe midline axis 108 lying along the sagittal plane. In otherembodiments, as shown in FIG. 5A, the grip 106 may be coupled to theinner surface 132 at a dynamic angle. In other embodiments, the couplingangle may be a non-perpendicular angle with respect to the midline axis108.

As shown in FIG. 4, the perianal support member 102 includes a height H1extending from an apex of the contact surface 104 to the distal tip ofthe compression members (e.g., a distal tip 128 a of the compressionmember 124). The height H1 may range from 1 cm to 10 cm. The grip 106includes a height H2 extending from a distal end 137 a (at the innersurface 132) to a proximal end 137 b. The height H2 may range from 3 cmto 30 cm. Although the height H2 of the grip 106 is greater than theheight H1 of the perianal support member 102, in other embodiments, theheight H2 may be less than the height H1 (e.g., as shown in FIGS. 13 and14). Although not limited to specific dimensions, the grip 106 includesa diameter Dg that may range from approximately 1 cm to 8 cm. As shownin FIG. 2, the grip 106 includes a cross-sectional area CA1 that mayrange from approximately 3 cm² to 25 cm². As shown in FIG. 3, thecontact surface 104 includes a cross-sectional area CA2. In the picturedembodiment, the cross-sectional area CA1 of the grip 106 issubstantially smaller than the cross-sectional area CA2 of the contactsurface 104 (indicated in part by the dotted area shown in FIG. 3). Inthe illustrated embodiment of FIGS. 2 and 3, the ratio of CA2:CA1 isgreater than 5:1. In other embodiments, the ratio of the cross-sectionalareas CA2:CA1 may be larger (e.g., the ratio CA2:CA1 may be 1 or greaterthan 1). For example, in the embodiment described below with respect toFIG. 13, the cross-sectional area CA2 of the grip (e.g., the grip 460)may be substantially similar to the surface area CA1 of the contactsurface 465. Other dimensions are contemplated, and the above dimensionsare supplied for exemplary purposes only.

The first compression element 116 and the second compression element 124meet at a first angle α1 to form the access cavity 136. In oneembodiment angle α1, is between 140 degrees and 30 degrees. In theillustrated embodiment, angle α1 is approximately 80 degrees. In theexample shown the first and second compression elements 116, 124 areintegral with and define a portion of the perianal support member 102.The distal end portion 118 of the compression element 116 transitionsinto the contact surface 104. In a similar manner, the distal end 126 ofthe compression element 124 transitions into the contact surface 104.The compression element 116 comprises an elongated, planar exterior sidewall 138 extending from the distal end 118 to the proximal end 120. Thecompression element 118 comprises an elongated, planar exterior sidewall 139 extending from the distal end 126 to the proximal end 128. Thecompression member 116 extends generally along an axis 140, which issubstantially transverse to the midline axis 108. The compressionelement 124 extends generally along an axis 142, which is substantiallytransverse to the midline axis 108. As shown in FIG. 4, the compressionelement 116 extends at an oblique angle α2 with respect to the axis 134(e.g., the sagittal plane extending through the midline axis 108), andthe compression element 118 extends at an oblique angle α3 with respectto the axis 134. It will be appreciated that in the illustratedembodiment, compression element 124 extends at an oblique angle α3substantially equal to the oblique angle α2 at which compression element116 extends with respect to axis 134. In some embodiments, the obliqueangles α2 and α3 are each within the range of about 5 to 25 degrees. Inother embodiments, the oblique angles α2 and α3 are each within therange of about 10 to 20 degrees, and in yet other embodiments, are witha range of about 15 to 20 degrees.

Referring back to FIG. 1, each compression element 116, 124 has a lengthL, and the maximum lateral distance of the access cavity 136 is definedby the distance D1 extending between the distal end portions 120, 128.In one embodiment, L is greater than 4 cm in length. In a preferredaspect, L is approximately 8 cm. In one embodiment, the maximum lateraldistance D1 of the access cavity 136 is greater than 4 cm. In theillustrated embodiment of FIG. 1, the maximum lateral distance isapproximately 10 cm.

The perianal support member 102 of the labor assistance system 100 hasthe internal contact surface 143 defined along the midline 108 opposingthe contact surface 104. It will be understood that a health careprovider may apply pressure to the contact surface 143 to move theperianal support member 102 into the operative position shown in FIGS. 1and 2 and/or apply additional pressure to apply pressure to (and, insome instances, compress) at least some perianal and/or perineal tissue.The first compression element 116 includes an interior wall 144 a whilethe second compression element 124 has an opposing interior wall 144 bgenerally facing the interior wall 144 a. The interior walls 144 a, 144b, along with the internal contact surface 143 define the access cavity136 within the labor assistance system 100. As shown in FIGS. 3 and 4,the configuration of the perianal support member 102 as described aboveresults in a generally wedge shaped device. Still further, with theinclusion of the access cavity 136, the perianal support member 102 hasa substantially V-shaped configuration with the contact surface 104defined at the apex of the V and the compression elements 116, 124forming the legs of the V. In other embodiments, as described below withreference to FIG. 8, the perianal support member may lack an accesscavity altogether.

FIGS. 2B and 2C illustrate partial perspective bottom views of the laborassistance system 100 positioned against a patient during two differentpressure situations during child delivery. In some embodiments, theperianal support member 102 is formed of an opaque material. In otherembodiments, the perianal support member 102 is formed of an opticallyclear material that enables the user to see through the compressionelements 116, 124 and/or the contact surface 104. For example, in thepictured embodiment, the perianal support member 102 is formed of aclear, transparent, translucent, or semi-translucent material. Thematerial composition of the perianal support member 102 allows the userto visually observe and/or measure the changes in tissue distension(e.g., secondary to pressure changes against the perianal support member102) occurring on the contact surface 104 and the exterior side walls138, 139 of the compression elements 116, 124, respectively, shown inFIG. 4. The clear, transparent, translucent, or semi-translucentmaterial of the perianal support member 102 allows the user to view thechanges in tissue distension through the perianal support member 102without removing the perianal support member 102 from the patient 10.

In the pictured example, FIG. 2B illustrates an area S1 that representsthe initial tissue spread against the perianal support member 102 uponan initial placement of the labor assistance system 100 on the patient10. FIG. 2C illustrates an area S2 that represents the subsequent tissuespread against the perianal support member 102 during different pressureconditions (e.g., as might occur during voluntary or involuntarycontractions, while the patient 10 pushes, and/or while the user appliesmore pressure to the perianal support member 102 through the grip 106).The user may observe the changes in tissue spread or tissue distensionto evaluate the changes in pressure associated with the progress oflabor. If the tissue spread is not adequate or is excessive, this mayindicate that the mother's labor or labor efforts (e.g., voluntarycontractions) are not progressing appropriately.

In some embodiments, as shown in FIGS. 2B and 2C, the perianal supportmember 102 includes markings 144 designed to indicate measurements, aruler, or a scale that assist the user in making precise measurementsand comparisons of tissue distention through different pressureconditions throughout the labor process. The markings 144 may compriseany variety of indicators (e.g., shapes, lines, colors) designed toconvey measurement data. The markings 144 may extend across the perianalsupport member from one compression element to the other, as shown, ormay extend along the contact surface along the midline axis 108 (e.g.,as shown in FIG. 22A). The markings 144 may be positioned across only aportion of the perianal support member 102, or may be positioned acrossthe entirety of the perianal support member 102. In some embodiments,the markings 144 may be on the contact surface 104 and the exterior sidewalls 138, 139 of the compression elements 116, 124, respectively, andin other embodiments, the markings 144 may be on the inner surface 132.

In some embodiments, the perianal support member 102 may lack predefinedmarkings for measurements, such as the markings 144 in FIGS. 2B and 2C.In such embodiments, the user may manually mark the perianal supportmember 102 (e.g., on the inner surface 132) to mark the relevant ordesired margins of the area S1 and the area S2, and then quantitatively(by measuring the difference in areas as indicated by the hashed area inFIG. 2C) or qualitatively (by visually observing the marked areas)compare the different degrees of tissue distension to evaluate theprogress of labor and/or the effectiveness of the pushing effort of thepatient 10. The user may use a marker or a grease pencil, by way ofnon-limiting example, to permanently or temporarily mark the perianalsupport member 102.

In the embodiment shown in FIGS. 3 and 4, the labor assistance systemincludes a pad 145 positioned on the contact surface 104. In someembodiments, the pad 145 has a width W1 that is substantially equivalentto a width W2 of the contact surface 104, and in other embodiments, asshown in FIG. 3, the pad 145 has a width W1 less than the width W2 ofthe contact surface 104. The anterior to posterior width W2 of thecontact surface 104 between the anterior edge 112 and the posterior edge110 is approximately 5 cm in the illustrated embodiment. This midlinewidth W2 can be adjusted in some embodiments depending on the amount andextent of perianal tissue that needs to be supported. In the embodimentshown the pad 145 extends along the contact surface 104 and extends atleast partially along the outer surface 130 of the perianal supportmember 102, covering at least a portion of the first compression element116 and the second compression element 124. The pad 145 may be disposedand arranged as an interfacing structure disposed between the contactsurface 104 of the perianal support member 102 and the patient'sperianal tissue 38 (shown in FIG. 1) when the labor assistance system100 is positioned in contact with the patient 10.

In some embodiments, the pad 145 comprises an anatomically conformablestructure. In some embodiments, the pad 145 comprises a compliant pad.In some instances, the pad 145 may be formed of a compliant materialsuch as, by way of non-limiting example, polyurethane, silicon, rubber,foam, or cotton. Such materials may enable the pad 145 to conform to thepatient's anatomy as the labor assistance system 100 is positioned incontact with the patient 10. In some embodiments, the pad 145 is formedof a material that retains its shape (e.g., a complementary shape to thepatient's tissue surface) upon removal of the pad 145 from the patient'stissue. For example, in some embodiments, the pad is formed of a clay orclay-like polymer that has a high degree of conformability when pushedagainst the patient, but retained that “conformed” shape upon removal ofthe pad 145 from the patient. In some embodiments, the pad 145 is asterile gauze pad. In other embodiments, the pad 145 includes aninternal cushioning structure, such as polyurethane, silicon, rubber,foam, cotton, etc., with a non-abrasive skin contact surface.

In other instances, the pad 145 comprises a hollow, inflatable structurethat may be selectively inflated with various amounts of fluids (e.g.,by way of non-limiting example, air, liquid, gels). In some embodiments,the pad 145 may be adjusted by the user to exhibit different degrees ofconformability. For example, in some embodiments, the pad 145 may beinflated through a tube 146 that may be attached to the pad 145 from afluid source 147. In some embodiments, the tube 146 is a detachable tubethat may be removed or disengaged from the pad 145 and/or the fluidsource 147. In some embodiments, the fluid source 147 comprises apump-like structure which may be electronically or manually operated toincrease or decrease the amount of fluid within the pad 145. In someembodiments, the fluid source 147 includes a control feature 148 thatallows the user to control the fluid ingress and/or egress from the pad145. In some instances, increasing the amount of fluid within the pad145 will increase the turgidity and lessen the degree of conformabilityof the pad 145. If the user fills the pad 145 with fluid, the pad 145may hold its shape and stop conforming to the patient's tissue contours.If, however, the pad 145 is incompletely filled with fluid, the pad 145may retain a high degree of conformability and assume a complementaryshape to the contours of the patient's tissue as the labor assistancesystem 100 is positioned in contact with the patient 10.

In some instances, the pad 145 is opaque. In other instances, the pad145 may be clear or translucent, thereby allowing the user to visuallyobserve changes in tissue distension through the pad (i.e., by observingchanges in the area of tissue contact against the pad 145 over time).The pad 145 may be adhered to the perianal support member 102 across themajority of the contact surface 104.

In one embodiment, the pad 145 is die cut from 1776 and 1772 stockmaterials from 3M. In another embodiment, pad 145 is an absorbentmaterial adapted to absorb bodily fluids. It will be appreciated thatthe pad 145 may make placement and application of the labor assistancesystem 100 more comfortable for the patient. In addition, the surface ofthe pad 145 is configured to frictionally engage the patient's perianaltissue to inhibit movement between the labor assistance system 100,particularly the contact surface 104 and the patient.

In still a further aspect, the pad 145 includes a treating compound. Thetreating compound can be disposed within the pad 145, applied on thesurface, or a combination of both. Treating compounds useful forcombination with pad 145 include, but without limitation to othercompounds, antibacterial compounds, antibiotic compounds, sclerants,antimicrobial compounds, anti-inflammatory compounds, anti-fungalagents, anti-itching agents, humicants, moisture absorbing agents, gasabsorbing agents, buffering agents for pH control, drying agents and thelike and coagulants.

In yet a further embodiment, the pad 145 is not fixed to the perianalsupport member 102 but is instead positioned on the patient in advanceof positioning the perianal support member 102 or is loosely held to theperianal support member 102 as it is applied to the body. In thisembodiment, the pressure applied via the grip 106 on the perianalsupport member 102 can maintain the position of the pad 145 relative tothe patient's body and in particular the anal orifice 26 (shown in FIG.1).

Returning to the embodiment shown in FIGS. 2B and 2C, the laborassistance system includes two securing members 149 a that terminate inanchor pads 149 b. The anchor pads 640 are shaped and configured to beremovably attached to the buttocks 14, 15 (e.g., within the glutealcleft 13) of the patient 10. The securing system is substantially thesame as described in U.S. Pat. No. 7,673,633, entitled “Apparatus andMethod of Inhibiting Perianal Tissue Damage,” which is herebyincorporated by reference in its entirety. In some embodiments, theanchor pads 149 b may be adhesively attached to the patient 10. In thepictured example, each securing member 149 a is fixedly coupled to oneof the compression elements 116, 124 and one of the anchor pads 149 b.In some examples, the securing members 149 a include a first half of areleasable fastening system coupled to the compression elements, such asa hook and loop system or a releasable adhesive system. In theillustrated embodiment, the anchor pads 149 b have a generallyrectangular shape that is shorter in length and wider than elongatedsecuring members 149 a. The shape of the anchor pad is shown forillustration purposes and may take any form that is suitable for fixingto a patient or inanimate object, as well as joining to the elongatedfixation member. Each anchor pad 149 b includes a first surface havingan adhesive surface (substantially similar to the adhesive surface 642described in more detail with relation to FIG. 15) adapted for joiningto the patient's skin or some inanimate object. The opposing surface(substantially similar to the adhesive surface 644 described in moredetail with relation to FIG. 15) includes the second half of thefastening system, which couples to the securing member 149 a. In someembodiments, at least a portion of a surface of the first surfaceincludes an adhesive coating that can fix the securing member to anotherobject. In one embodiment, the adhesive coating is adapted forreleasably adhering to a patient's skin.

FIG. 5A shows a side view of an exemplary labor assistance system 100′according to one embodiment of the present disclosure, and FIG. 5B showscutaway side view of the labor assistance system 100′. The laborassistance system 100′ is substantially similar to the labor assistancesystem 100 except for the differences described herein. For example, thelabor assistance system 100′ includes a grip 106′ movably coupled to aninner surface 132′ of a perianal support member 102′ at a pivot element150. The pivot element 150 may comprise any of a variety of couplingelements configured to permit the grip 106′ to move with respect to amidline axis 108′ of a contact surface 104′ of the perianal supportmember 102′. For example, the pivot element 150 may comprise, withoutlimitation, a hinge, a rotatable ball-and-socket joint, a knuckle joint,a pin joint, and a screw joint. As shown in FIG. 5B, the pivot element150 may be spaced by a distance or gap G1 from the contact surface 104′of the perianal support member 102′. In the pictured embodiment, thegrip 106′ is shown positioned at a non-perpendicular angle with respectto the midline axis 108′. A longitudinal axis 134′ of the grip 106′intersects the midline axis 108′ to form an acute angle α4 and, as shownin FIG. 5B, an obtuse angle α5. In some embodiments, the pivot element150 couples the grip 106′ to the perianal support member 102′ at thedynamic angle α4 which changes in response to the actions of the userholding the grip 106′ and/or the movements of the patient 10. As shownin FIG. 5B, in some embodiments, the pivot element 150 couples the grip106′ the perianal support member 102′ in a manner that allows the grip106′ to be repositioned anywhere within the 180° degree arc indicated byangles α4 and α5. In other embodiments, the pivot element 150 includes alocking feature 152 that enables the user to temporarily and reversiblylock or fix the angle α4. The locking feature 152 may be positioned onthe grip 106′ and/or the perianal support member 102′. The lockingfeature 152 may include any variety of locking means shaped andconfigured to temporarily lock the grip 106′ in at a fixed angle α4relative to the midline axis 108′. For example, by way of non-limitingexample, the locking feature 152 may comprise a protrusion on the grip106′ configured to mate with a depression on the inner surface 132′. Inthe pictured embodiment, the grip 106′ is coupled to the inner surface132′ at a position closer to an anterior edge 112′ than a posterior edge110′ of the perianal support member 102′. In other embodiments, thepivot element 150 (and the grip 106′) may be spaced closer to theposterior edge 110′.

FIGS. 6-9 illustrate different embodiments of a perianal support memberaccording to various embodiments of the present disclosure. The perianalsupport members described herein may be combined or coupled with any ofthe grips described in this disclosure to form various labor assistancesystems. For purposes of illustration, the grip 106 is shown in dottedlines coupled to the exemplary perianal support members shown in FIGS.6-9. The grips may be coupled to the exemplary perianal support membersvia a pivot element (e.g., the pivot element 150 described above). Inother embodiments, the grips may be attached to the exemplary perianalsupport members in a fixed relationship.

The grips extend from the perianal support member and are configured andarranged to permit the patient to adjust the relative position andorientation of the labor assistance system. The adjustment may includemodifying the pressure applied by the perianal support member on theperianal tissue or may include adjusting the physical location of theperianal support member on the patient. Accordingly, during contractionsor during pushing, the user can apply additional pressure on theperianal and/or perineal tissue if desired. Therefore, the user has somelevel of control of the pressure on the perianal and/or perineal tissue.

When additional pressure loading is desired, the user may press on thegrip in the general direction of the patient's head so that the perianalsupport member applies additional loading onto the perianal tissue. Insome embodiments, the user may monitor the push strength of the patient,the force, duration, and strength of intrauterine contractions, and/orother markers of the progression of labor described herein, and mayadjust the labor assistance system using the grip to maintain theapplied pressure against the patient in a desired pressure range. Thegrip allows a user to quickly and easily adjust the relative positionand orientation of the perianal support member on the perianal tissueand to increase or decrease the pressure on the perianal tissue. Inparticular, the user may adjust the position or the pressure applied bythe perianal support member by manipulating the grip relative topatient.

FIG. 6 illustrates a perspective view of an exemplary perianal supportmember 160 according to one embodiment of the present disclosure. Theperianal support member 160 is substantially similar to the perianalsupport member 102 except for the differences described herein. Unlikethe perianal support member 102, which has a V-shaped side profile, theperianal support member 160 has a generally U-shaped side profile. Theperianal support member 160 includes a curved or rounded contact surface162 and an opposing inner surface 164. A grip (e.g., the grip 106discussed above) may be coupled to and extend from the inner surface164. The perianal support member 160 includes compression elements 166and 168 that flank the contact surface 162 and have substantially thesame radius of curvature as the contact surface 162. In someembodiments, the compression elements 166, 168 are integral extensionsof the contact surface 162. In other embodiments, the compressionelements 166, 168 are coupled to the contact surface 162. Thecompression elements 166, 168 may extend equal distances from thecontact surface 162, as shown in FIG. 6, or they may extend unequal ordifferent distances from the contact surface 162. For example, in someembodiments, the compression element 166 may include a length L1 that isless than or greater than a length L2 of the compression element 168.

FIG. 7 illustrates a perspective view of an exemplary perianal supportmember 170 according to one embodiment of the present disclosure. Theperianal support member 170 is substantially similar to the perianalsupport member 102 except for the differences described herein. Unlikethe perianal support member 102, which has a V-shaped side profile, theperianal support member 170 has a trapezoidal side profile. The perianalsupport member 170 includes a flat contact surface 172 and an opposinginner surface 174. A grip (e.g., the grip 106 discussed above) may becoupled to and extend from the inner surface 174. The perianal supportmember 170 includes compression elements 176 and 177 that flank thecontact surface 172. The compression elements 176, 177 include innersurfaces 178, 179, respectively. In some embodiments, the compressionelements 176, 177 are integral extensions of the contact surface 172. Inother embodiments, the compression elements 176, 177 are coupled to thecontact surface 172. The compression elements 176, 177 may extend equaldistances from the contact surface 172, as shown in FIG. 7, or they mayextend unequal or different distances from the contact surface 172. Forexample, in some embodiments, the compression element 176 may include alength L3 that is less than or greater than the length L4 of thecompression element 177.

In an alternative form, a compliant pad 173 (shown in dash) is added tothe contact surface 172. It is joined to the surface 172 by adhesive orany suitable joining technique. In one method, the pad 173 may be aseparate component that is positioned on the patient before the supportmember 170 is positioned in a supporting fashion on the patient. In someembodiments, the pad 173 comprises an anatomically conformablestructure. In some embodiments, the pad 173 comprises a compliant pad.In some instances, the pad 173 may be formed of a compliant materialsuch as, by way of non-limiting example, polyurethane, silicon, rubber,foam, or cotton. Such materials may enable the pad 173 to conform to thepatient's anatomy as the labor assistance system 170 is positioned incontact with the patient 10. In some embodiments, the pad 173 is formedof a material that retains its shape (e.g., a complementary shape to thepatient's tissue surface) upon removal of the pad 173 from the patient'stissue. For example, in some embodiments, the pad is formed of a clay orclay-like polymer that has a high degree of conformability when pushedagainst the patient, but retained that “conformed” shape upon removal ofthe pad 173 from the patient. In some embodiments, the pad 173 is asterile gauze pad. In other embodiments, the pad 173 includes aninternal cushioning structure, such as polyurethane, silicon, rubber,foam, cotton, etc., with a non-abrasive skin contact surface.

In other instances, the pad 173 comprises a hollow, inflatable structurethat may be selectively inflated with various amounts of fluids (e.g.,by way of non-limiting example, air, liquid, gels). In some embodiments,the pad 173 may be adjusted by the user to exhibit different degrees ofconformability. For example, in some embodiments as described above withrespect to FIG. 3, the pad 173 may be inflated through a tube that maybe attached to the pad 173 from a fluid source. In some instances,increasing the amount of fluid within the pad 173 will increase theturgidity and lessen the degree of conformability of the pad 173. If theuser fills the pad 173 with fluid, the pad 173 may hold its shape andstop conforming to the patient's tissue contours. If, however, the pad173 is incompletely filled with fluid, the pad 173 may retain a highdegree of conformability and assume a complementary shape to thecontours of the patient's tissue as the labor assistance system 170 ispositioned in contact with the patient.

FIG. 8 illustrates a perspective view of an exemplary perianal supportmember 180 according to one embodiment of the present disclosure. Theperianal support member 180 is substantially similar to the perianalsupport member 102 except for the differences described herein. Unlikethe perianal support member 102, which has a V-shaped, concave sideprofile, the perianal support member 180 has a curved, dome-like, solidside profile. The perianal support member 180 is shaped and configuredas a solid shape having an arcuate contact surface 182. The perianalsupport member 180 includes the curved or rounded contact surface 182and an opposing inner surface 184. The inner surface 184 forms asubstantially flat, planar surface. Thus, the perianal support member180 lacks an access cavity (e.g., the access cavity 136 shown in FIG.3). In other embodiments, the inner surface 184 may be slightly convexor slightly concave. A grip (e.g., the grip 106 discussed above) may becoupled to and extend from the inner surface 184. The perianal supportmember 180 includes compression elements 186, 188 that form integral orcontinuous extensions of the contact surface 182.

FIG. 9A illustrates a perspective view of an exemplary perianal supportmember 190 according to one embodiment of the present disclosure. Theperianal support member 190 is substantially similar to the perianalsupport member 102 except for the differences described herein. Forexample, the perianal support member 190 includes a contact surface 192extending along a midline axis 193 from a posterior edge 194 to ananterior edge 195. An opposing inner surface 196 defines an accesscavity 197. A grip (e.g., the grip 106 discussed above) may be coupledto and extend from the inner surface 196. The perianal support member190 includes compression elements 198 and 199 that flank the contactsurface 192. In some embodiments, the compression elements 198, 199 areintegral extensions of the contact surface 192. In other embodiments,the compression elements 198, 199 are coupled to the contact surface192. The compression elements 198, 199 may extend equal distances fromthe contact surface 192, as shown in FIG. 9A, or they may extend unequalor different distances from the contact surface 192. For example, insome embodiments, the compression element 198 may include a length L5that is less than or greater than a length L6 of the compression element199.

The perianal support member 190 includes a focusing pressure element orfocal protrusion 200 disposed on the contact surface 192. In thepictured embodiment, the focusing pressure element 200 comprises araised protrusion extending outwardly from the contact surface 192 awayfrom the compression elements 198, 199 and having a curved shape. Inother embodiments, the focusing pressure element 200 may comprise anystructure shaped and configured to apply a focal area of increasedpressure upon the perianal region 38 or perineal region of the patient10 (shown in FIG. 1). For example, without limitation, the focusingpressure element 200 may comprise a textured area (e.g., having adifferent texture than the remainder of the contact surface 192), aprotrusion having a polygonal shape, or a plurality of protrusions orridges. In the pictured embodiment, the focusing pressure element 200 isspaced farther from the posterior edge 194 than the anterior edge 195.This configuration enables the user to position the perianal supportmember 190 against the patient 10 such that the focusing pressureelement 200 abuts the perineal region between the anal orifice 26 andthe vaginal opening 11 (shown in FIGS. 1 and 2) without obstructing thevaginal opening 11. In other embodiments, the focusing pressure element200 may be spaced equidistant from the anterior edge 195 and theposterior edge 194, or may be positioned closer to the posterior edge194 than the anterior edge 195. In the pictured embodiment, the focusingpressure element 200 includes a length L7 along the axis 193 that isless than a length L8 of the contact surface 192. In other embodiments,the length L7 of the focusing pressure element 200 may comprise anyfraction of the length L8 of the contact surface 192. For example, thelength L7 may comprise one-fourth, one-third, or one-half the length L8of the contact surface.

In some embodiments, the perianal support member 190 may include apressure sensor 202 on the contact surface 192. In the picturedembodiment, the pressure sensor 202 is positioned on the focusingpressure element 200. In other embodiments, the pressure sensor 202 maybe found on another part of the contact surface 192. In someembodiments, the pressure sensor 202 may protrude outward from thecontact surface 192 and may be configured to extend completely orpartially into the patient's anal canal. In other embodiments, thepressure sensor 202 may be configured for external placement against thepelvic tissues (e.g., perianal tissue) of the patient 10. The pressuresensor 202 may be includes on any of the perianal support memberembodiments described herein.

In some embodiments, the perianal support member 190 may include ahaptic feedback generator 203, which may be positioned on the innersurface 196 as shown in the pictured embodiment or, on the contactsurface 192, or on the grip 106. In some embodiments, the hapticfeedback generator 203 may be positioned on the focusing pressureelement 200. In other embodiments, the haptic feedback generator 203 maybe found on another part of the contact surface 192. In someembodiments, the haptic feedback generator 203 may be configured toprovide haptic feedback to the user and/or the patient 10 via any typeof suitable tactile feedback (e.g., by way of non-limiting example,vibrations, forces, or motions) through the perianal support member 190and/or the grip 106. In some embodiments, the haptic feedback generator203 may be connected to the pressure sensor 202 (either wirelessly orthrough a wired connection) to provide varying degrees of hapticfeedback depending upon the amount of pressure registered by thepressure sensor 202. For example, in one instance, the haptic feedbackgenerator 203 may provide increasing (e.g., stronger or faster)vibrations through the perianal support member 190 when a pressureincrease is sensed by the pressure sensor 202. The haptic feedbackgenerator 203 may be included on any of the labor assistance systemembodiments described herein.

In use, the user (e.g., the health care provider, the patient, oranother) can position the perianal support member 190 against thepatient's perianal region 38 or perineal region to apply increasedpressure to the focal area in contact with the focusing pressure element200. In some embodiments, this focused application of increased pressure(relative to the surrounding tissues) stimulates a nerve or bundle ofnerves to enhance the pushing reflex in the patient 10 (e.g., similar tothe Ferguson reflex). For example, a user may push the grip 106 at theappropriate angle to transfer sufficient pressure through the focusingpressure element 200 against a focal area of the perianal or perinealregion of the patient 10 to stimulate the patient's urge to push thechild out of the birth canal. In other instances, the focal applicationof pressure through the pressure element 200 against the perianal orperineal region of the patient 10 may assist in guiding the child's headand body along an optimal route through the vaginal canal.

FIG. 9A shows a visual indicator or marker 205 that can assist a user inproperly positioning the perianal support member 190 on the patient 10.In this example, the marker 205 is an elongated shape formed on thecontact surface 192 of the perianal support member 190 that extends ontothe compression elements 198, 199. In other embodiments, the marker 205may have any of a variety of shapes or patterns, including, withoutlimitation, oblong, round, ovoid, target-shaped, or striped. In someembodiments, the marker 205 may comprise a window (e.g., either an opencut-out from the perianal support member 190 or a solid window formed ofa suitably clear material) that allows the user to see through theperianal support member 190 during and after placement of the perianalsupport member 190 on the patient 10. In other embodiments having aclear or translucent contact surface 192, where the user may visuallyobserve the spread of tissue contacting the contact surface 192 throughthe member 190, the marker 205 may comprise a manually drawn marking onthe contact surface 192 or the inner surface 196 that marks a particularanatomic reference structure, point, margin, or distance for the user.In some embodiments, the user may mark the a first location on the innersurface 196 to indicate the initial margin of tissue contacting thecontact surface 192 after the initial placement of the perianal supportmember 190 on the patient 10, and then mark a second location on theinner surface 196 to indicate the spreading margin of tissue contactingthe contact surface 192 after the change in pressure relationshipsbetween the contact surface 192 and the patient 10. The user can measurethe distance between the first and second markings to evaluate theextent of tissue distension and pressure changes and analyze theprogress of labor.

In use, the user can align the marker 205 with a body reference marker,such as the anus or anal orifice 26 (shown in FIG. 1). This may helpensure that the perianal support member 190 is properly located to applyfocal pressure through the focusing pressure element 200 in the correctarea (e.g., to stimulate the pushing reflex and/or give the patient aphysical focal point to direct the pushing effort), to properly shapethe exit portion of the vaginal canal to facilitate the baby's egressfrom the birth canal, and/or to support or treat perianal tissue whilemaintaining suitable spacing from the vaginal opening.

The other embodiments of perianal support members described herein(e.g., perianal support members lacking the focusing pressure element200) may also include a marker 205. Application of the perianal supportmember 190 on the patient 10 is described further below in relation toFIG. 16B.

FIG. 9B illustrates a perspective view of the exemplary perianal supportmember shown in FIG. 9A including two securing members 210 a, 210 b thatterminate in anchor pads 212 a, 212 b. The anchor pads 212 a, 212 b areshaped and configured to be removably attached to the buttocks 14, 15(e.g., within the gluteal cleft 13) of the patient 10 (in a similarfashion as shown in FIG. 2C). In some embodiments, the anchor pads 212a, 212 b may be adhesively attached to the patient 10. In the picturedexample, the securing members 210 a, 210 b are fixedly coupled to thecompression elements 198, 199 and the anchor pads 212 a, 212 b,respectively. In some examples, the securing members 210 a, 210 binclude a first half of a releasable fastening system coupled to thecompression elements 198, 199, such as a hook and loop system or areleasable adhesive system. In the illustrated embodiment, the anchorpads 212 a, 212 b have a generally rectangular shape that is shorter inlength and wider than elongated securing members 210 a, 210 b. The shapeof the anchor pads 212 a, 212 b is shown for illustration purposes andmay take any form that is suitable for fixing to a patient or inanimateobject, as well as joining to the elongated fixation member. Each anchorpad 212 a, 212 b includes a first surface 214 a, 214 b having anadhesive surface (substantially similar to the adhesive surface 642described in more detail with relation to FIG. 15) adapted for joiningto the patient's skin or some inanimate object. The opposing surface 216a, 216 b (substantially similar to the surface 644 described in moredetail with relation to FIG. 15) includes the second half of thefastening system, which couples to the securing member 210 a, 210 b,respectively. In some embodiments, at least a portion of a surface ofthe first surface 214 a, 214 b includes an adhesive coating that can fixthe securing member to another object. In one embodiment, the adhesivecoating is adapted for releasably adhering to a patient's skin.

In addition to including different types of perianal support members, asdescribed above, various embodiments of the labor assistance systems mayinclude different types of grips. In this regard, FIGS. 10-12 illustratethe perianal support member 102 coupled to a variety of differentexemplary grips, and FIGS. 13 and 14 illustrate a perianal supportmember 455 coupled to a variety of different exemplary grips. Thedifferent types of grips are meant to be illustrative only, and are inno way limiting. Other types of grips are contemplated. In addition, itshould be understood that each of the different perianal support membersand grips described herein can be combined in any of a variety ofcombinations to create labor assistance systems having differentconfigurations and pressure-application characteristics.

FIG. 10 illustrates an exemplary labor assistance system 300 includingthe perianal support member 102 coupled to an exemplary grip 305. Thegrip 300 is substantially similar to the grip 106 described above exceptfor the differences described herein. The grip 300 is shaped as a“T-bar” including a shaft 310 and a bar 315. The bar 315 extending froman end 316 to an end 317, and is attached to the shaft 310 at a midpoint318 to form two sections 320 a and 320 b on either side of the shaft310. In the pictured embodiment, the section 320 a has approximately asame length L9 as a length L10 of the section 320 b. In otherembodiments, the bar 315 may be positioned such that the sections 320 a,320 b are not of equal lengths. In some embodiments, bar 315 may beattached to the shaft 310 to form an “L-bar” shape (e.g., with the shaft310 meeting the bar 315 at one end 316 or 317 instead of the midpoint318). In the pictured embodiment, the bar 315 is disposed substantiallyperpendicular to the shaft 310. In other embodiments, the bar 315 may bedisposed at an oblique angle with respect to the shaft 310. The bar 315forms a handle for the user to hold while positioning and maintainingthe labor assistance system 300 against the patient 10. For example, insome instances, the user may wrap his or her fingers around the sections320 a, 320 b to obtain a secure grasp of the grip 305.

In some embodiments, the bar 315 (and/or the shaft) may includegrip-enhancing features that enhance the graspability of the grip 305such as, by way of non-limiting example, through holes 325 that enable aportion of the user's hand or fingers to extend therethrough. In otherembodiments, the bar 315 (and/or the shaft 310) may includegrip-enhancing features such as, by way of non-limiting example,indentations or protrusions that allow a portion of the user's hand orfingers to conform to or rest within. In other embodiments, the bar 315(and/or the shaft 310) may be coated with polyurethane or other frictionenhancing material to allow the patient to comfortably grip the grip 305and provide pressure. Such grip-enhancing features may be found in anyof the variety of grips described herein.

FIG. 11 illustrates an exemplary labor assistance system 350 includingthe perianal support member 102 coupled to an exemplary grip 355. Thegrip 355 is substantially similar to the grip 106 described above exceptfor the differences described herein. The grip 355 includes an innershaft 360 received within a hollow cylindrical portion of outer shaft362 such that the inner shaft can telescope within the outer shaft. Aspring 367 is positioned within the hollow cylindrical portion of theouter shaft and is compressed between inner shaft end 361 and outershaft shoulder 364. The outer shaft 362 terminates in a knob 365. Theknob 365 forms a graspable portion for the user to hold whilepositioning and maintaining the labor assistance system 350 against thepatient 10. For example, in some instances, the user may wrap his or herhand around the knob 365 to obtain a secure grasp of the grip 355 whilepositioning and maintaining the labor assistance system 350 inpressurized engagement with the patient 10. In some instances, the knob365 may be shaped and sized to comfortably fit in an average user'spalm. The spring has a stiffness that maintains the amount of force theuser can apply to the patient even at multiple knob position along thedirections of arrow T. For example, if the user applies significantforce to knob, the force will overcome the spring force and the knobwill move in the direction of arrow T toward the patient. If the user'shand moves slightly away from the patient, the spring will move the knobaway from the patient in the direction of arrow T and maintainsubstantially constant pressure on the patient even if the user's handmoves in and out in the directions of arrow T.

FIG. 12 illustrates an exemplary labor assistance system 400 includingthe perianal support member 102 coupled to an exemplary grip 405. Thegrip 405 is substantially similar to the grip 106 described above exceptfor the differences described herein. The grip 405 includes a shaft 405that terminates in a tab 410 having a central portion 415 and a raisedrim 420. The tab 410 forms a graspable portion for the user to holdwhile positioning and maintaining the labor assistance system 400against the patient 10. For example, in some instances, the user maywrap his or her fingers around the tab 410 to obtain a secure grasp ofthe grip 405 while positioning and maintaining the labor assistancesystem 400 in pressurized engagement with the patient 10. In someembodiments, the tab 410 forms an annular ring and the central portion415 forms an aperture through which a user may pass one or more fingers.In other embodiments, instead of an aperture, the central portion 415forms a central depression encircled by the raised rim 420.

FIG. 13 illustrates an exemplary labor assistance system 450 includingthe exemplary perianal support member 455 coupled to an exemplary grip460. The perianal support member 455 is substantially similar to theperianal support member 102 described above except for the differencesdescribed herein. In particular, the perianal support member 455includes a more rounded contact surface 465 and internal contact surface470 than the contact surface 104 and internal contact surface 143 of theperianal support member 102. The grip 460 comprises an elongate, hollowtube that is coupled to the internal contact surface 470. In someembodiments, the grip 460 may extend the entire length L10 of theinternal contact surface 470, which extends from an anterior edge 472 toa posterior edge 474. In other embodiments, the grip 460 may extend onlypartially along the length L10. For example, in some embodiments, thegrip 460 may not extend to the anterior edge 472 and/or the posterioredge 474. In the pictured embodiment, the grip 460 forms a hollowcylinder having a passageway 475, through which the user may extend oneor more fingers. Although the pictured embodiment shows the grip 460having a circular side profile (e.g., the circular side profile of acylindrical tube) the grip 460 may form a tube having any of a varietyof side profile shapes. The grip 460 extends along the midline axis 108.In use, a user may slide one or more fingers through the passageway 475and apply pressure towards the contact surface 465 to position andmaintain the labor assistance system 400 against the patient 10. Forexample, in some instances, the user may push his or her fingers in thedirection of the arrow A1 within the passageway 475 to maintain thelabor assistance system 400 in pressurized engagement with the patient10. In some embodiments, the grip 460 may form a tunnel or channel 480through the perianal support member 455 through which a user may passone or more fingers (instead of comprising a separate tubular element asshown in FIG. 13). In such embodiments, the perianal support member 455may be thicker than shown in FIG. 13 (e.g., with a greater distancebetween the contact surface 465 and the internal contact surface 470).

FIG. 14 illustrates an exemplary labor assistance system 500 includingthe exemplary perianal support member 455 coupled to an exemplary grip510. The perianal support member 455 includes an inner surface 505disposed opposite an outer surface 508, which extends across theperianal support member 455 to include the contact surface 465. The grip510 comprises a curved support structure or compliant pad that iscoupled to the inner surface 505. In some embodiments, the grip 510substantially mimics the shape and contour of the perianal supportmember 455. For example, in the pictured embodiment, the grip 510 formsa curved, wedge-shaped structure including an upper surface 515 that hasthe same curvature and contour as the inner surface 505 of the perianalsupport member 455. In some embodiments, the grip 510 may extend theentire length L10 of the internal contact surface 470, which extendsfrom the anterior edge 472 to the posterior edge 474. In otherembodiments, the grip 510 may extend only partially along the lengthL10. For example, in some embodiments, the grip 510 may not extend tothe anterior edge 472 and/or the posterior edge 474. Although thepictured embodiment shows the grip 510 having a side profile thatsubstantially mimics the side profile of the perianal support member 455(e.g., a wedge or curving V-shaped side profile), the grip 510 may haveany of a variety of side profile shapes provided that the upper surface515 is configured to contact the inner surface 505 of the perianalsupport member 455.

In use, a user may press one or more fingers against a lower surface 520of the grip 510 and apply pressure towards the contact surface 465 toposition and maintain the labor assistance system 400 against thepatient 10. For example, in some instances, the user may push his or herfingers in the direction of the arrow A2 to maintain the laborassistance system 400 in pressurized engagement with the patient 10. Insome embodiments, the grip 510 comprises a pad of compliant materialthat conforms or molds to the pressure applied by the user's fingers. Inother embodiments, the grip 510 comprises a pad of non-compliantmaterial. In some embodiments, the grip 510 may form an integralextension of the perianal support member 455 (instead of comprising aseparate element as shown in FIG. 14). In some embodiments, the grip 510can provide additional structural support for the perianal supportmember 455 as the user pushes the contact surface 465 against thepatient 10. In some embodiments, the grip 510 can help the perianalsupport member 455 better conform to the patient 10, particularly whenthe contact surface 465 includes a conformable material. In someembodiments, the labor assistance system 500 also includes a handle-likegrip (e.g., the grip 106) coupled to the grip 510.

In some embodiments, contact surface 465 includes a conformablematerial. Details of the types of materials and certain properties thatmay form contact surface 465 are described in detail with respect to theembodiment of FIG. 7. In at least one aspect, contact layer 465comprises a material that deforms under compressive force of 1-10 poundsof pressure applied to the grip, and more preferably deforms at loads of3-7 pounds of pressure applied to the grip. These same properties may beexperienced with use of pad 173 described with respect to FIG. 7.

FIG. 15 illustrates an exemplary labor assistance system 600 positionedwithin the gluteal cleft 13 of the patient 10. In particular, FIG. 15shows the labor assistance system 600, including a perianal supportmember 605 and a grip 610, and a push evaluation system 615. In someembodiments, the push evaluation system 615 is integrally formed withcomponents of the labor assistance system 600 discussed above. That is,in some embodiments, the push evaluation system 615 is a part of thelabor assistance system 600. In other embodiments, the push evaluationsystem 615 is associated with the support system 100 in a mannerenabling the push evaluation system 615 to monitor or detect thepressure on the labor assistance system 600 or on the patient. Theperianal support member 605 is substantially similar to the perianalsupport member 102 except for the differences described herein. Forexample, the perianal support member 605 is sized and shaped to fitwithin the gluteal cleft 13 of the patient 10. In particular, in thepictured embodiment, compression members 620 a, 620 b are shaped andsized to extend within the gluteal cleft 13 without extending past thegluteal cleft 13. The grip 610 may be substantially similar to the grip106 except for the differences described herein. For example, the grip610 in the pictured embodiment is coupled to the push evaluation system615. The grip 610 includes a series of markings 612. The markings 612may be used to indicate the amount of anal displacement, the amount ofdisplacement of the perianal support member 605, and/or the amount offorce or pressure applied to the perianal support member 605.

The push evaluation system 615 is shaped and configured to measure andconvey the extent of the pushing force applied by the patient 10 on acontact surface 625 of the perianal support member 605. The pushevaluation system 615 may be configured and arranged to detect changesin pressure, stress, or strain, either directly or indirectly, that maybe indicative of the amount of force being applied on the laborassistance system 600 by the patient 10. The push evaluation system 615may be associated and configured with other components of the laborassistance system 600, such as the perianal support member 602 or thegrip 610. For example, the push evaluation system 615 in the picturedembodiment is coupled to the grip 610. For example, the push evaluationsystem 615 may directly measure pressure or force upon the perianalsupport member 605 using pressure sensors, or may indirectly measurepushing force by detecting and conveying changes in the shape,structure, or arrangement of various components or elements making upthe labor assistance system 600.

In the pictured embodiment, the push evaluation system 615 comprises aspring-loaded device including a spring 630 having two securing members149 a that terminate in anchor pads 149 b. The anchor pads 149 b areshaped and configured to be removably attached to the buttocks 14, 15(e.g., within the gluteal cleft 13) of the patient 10. In someembodiments, the anchor pads 149 b may be adhesively attached to thepatient 10. In the pictured example, the securing members 149 a arefixedly coupled to the spring 630 and the anchor pads 149 b. In someexamples, the securing members 149 a include a first half of areleasable fastening system coupled to the spring 630, such as a hookand loop system or a releasable adhesive system. In the illustratedembodiment, the anchor pads 149 b have a generally square shape that isshorter in length and wider than elongated securing members 149 a. Theshape of the anchor pad is shown for illustration purposes and may takeany form that is suitable for fixing to a patient or inanimate object,as well as joining to the elongated fixation member. Each anchor pad 149b includes a first surface 642 having an adhesive surface adapted forjoining to the patient's skin or some inanimate object. The opposingsurface 644 includes the second half of the fastening system, whichcouples to the securing member 149 a. In some embodiments, at least aportion of a surface of the first surface 642 includes an adhesivecoating that can fix the securing member to another object. In oneembodiment, the adhesive coating is adapted for releasably adhering to apatient's skin.

The push evaluation system 615 is configured to monitor uterinecontractions and pushing by the patient by reflecting the force and/orpressure applied on the perianal support member 605 by the anal orifice26 and the perianal tissue 38. That is, during contractions, the pushevaluation system 615 described herein may be configured to detect achange in pushing force and pressure that occurs due to muscledisplacement or distention of the perianal tissue (e.g., caused by thecontractions and pushing effort of the patient 10). During labor, thecontractions of the uterus, along with movement of the baby's head as aresult of the uterine muscles, physically displace the perianal tissue.When the perianal tissue is supported by the perianal support membersdescribed herein, the result is less perianal tissue displacement and anincrease in net pressure and force against the contact surface 625 ofthe perianal support member 605. These increases in pressure against thecontact surface 625 can be detected using the push evaluation system615. In particular, as the pushing force increases toward the laborassistance system 600, the perianal support member 605 will move in thedirection of the force as indicated by the arrow A3. As the perianalsupport member 605 moves a distance D1 from a first position 645 to asecond position 650 in response to the displacement of the perianaltissue, the grip 610 can slide within the spring 630 in the direction ofthe arrow A3 from a third position 655 to a fourth position 660.Although the movement of the grip 610 may compress the spring 630, thesecuring members 149 a and the anchor pads 149 b remain substantiallyfixed in place relative to the patient 10. The greater the pushing forceand/or effort of the patient 10, the greater the distance D1 theperianal support member 605 will shift away from the line 645.

This distance D1 and pushing force may be reflected by the markings 612on the grip 610 relative to the securing members 149 a. For example, inone embodiment, when the contact surface 625 of the perianal supportmember 605 is positioned relative to the anal orifice 26 at the firstposition 645, the marking 612 c may be level with or adjacent to thesecuring member 149 a. As the patient pushes, the perianal supportmember 605 may shift downward by the distance D1 until the contactsurface 625 is positioned at the second position 650, simultaneouslyshifting the grip 610 the distance D1 from the line 655 to the line 660.When the grip 610 is positioned at the line 660, the marking 612 a maybe level with or adjacent to the securing member 149 a, indicating thechange in force and/or pressure applied to by the patient's pushing uponthe perianal support member 605. Accordingly, in addition to measuringthe pushing force and pressure statically upon application of the laborassistance system 600, the push evaluation system 615 may be used tomonitor dynamic force and pressure by detecting changes in force andpressure on the labor assistance system 600 resulting from uterinecontractions ad maternal pushing.

In addition, by monitoring the changes in pressure on the perianaltissue by the perianal support member 605 that occur during a push, thepressure detection systems may be able to provide a pressure indicationof the strength of a push. Accordingly, during the birthing process, thepatient and/or the healthcare provider may observe the system 615 todetermine the strength of a push. The position of the markings 612 onthe grip 610 relative to the securing members 149 a may suggest whetheror not the patient is effectively pushing the baby toward the vaginalopening during a contraction. Moreover, if the grip 610 compresses thespring 630 to the extent that the position of the markings 612 relativeto the securing members 149 a can no longer change, the user may bealerted to a pushing effort by the patient 10 in an unsafe force orpressure range. This may indicate that pressure on the perianal tissueshould be reduced, and the user may instruct the patient 10 to haltpushing and/or remove the labor assistance system 600 from contact withthe patient 10. Therefore, this condition alerts the user and patient 10to either cease the pushing contractions and/or to reposition or removethe labor assistance system 600. As such, the push evaluation system 615may provide positive user feedback on dynamic pressure changesindicative of the success or lack thereof of pushing associated withcontractions. It's worth noting that the labor assistance system 600 maybe retained in position on the patient 10 both during the static supportphase and the dynamic support phase of the birthing process.

The push evaluation systems disclosed herein may enable a health careprovider of the patient to apply the labor assistance system with atleast a proper amount of pressure to provide therapeutic support to thepatient during childbirth. Accordingly, by evaluating the strength andeffectiveness of the patient's pushing and adjusting the position andpressure application of the labor assistance system accordingly,utilizing the systems disclosed herein may reduce the incidence of anumber of complications, including for example and without limitation,pelvic floor incompetence or dysfunction, organ prolapse, incontinencesecondary to pressure and stretching exerted on bladder and bladderneck, over stretching, perineum tears and lacerations, forceps use, andhemorrhoids.

Returning now to FIGS. 1 and 2, in use the user (e.g., the patient 10, ahealth care provider, or another) positions the patient 10 to expose theperianal region 38. During the child birthing process, the patient 10may be positioned in stirrups attached to a delivery table (not shown).The labor assistance system 100 is then moved adjacent the gluteal cleft13 between the buttocks 14 and 15. The support system 100 is positionedsuch that the midline axis 108 of the perianal support member 102 issubstantially aligned with the patient's midline within the sagittalplane. Referring to FIG. 1, the perianal support member 102 is advancedin the direction of arrow A4 toward the anal orifice 26 (generallywithin the sagittal plane toward the head of the patient 10) to bringthe contact surface 104 into contact with the perianal tissues 38.Continued advancement of the perianal support member 102 toward the analorifice 26 applies pressure through the contact surface 104 and thecompression members to the perianal tissues. The user may hold the grip106 to position the perianal support member 102 within the gluteal cleft13 and to advance the perianal support member 102 against the perianaltissues 38. In one aspect, the healthcare provider may place at leastone finger within the access cavity 136 and preferably against the innersurface 132 to further advance the device against the anal orifice 26.

The user may utilize the pressure feedback (e.g., tactile or hapticfeedback) associated with the labor assistance system 100, the pushevaluation system 615, and/or an intrauterine contraction monitor tosense whether the patient 10 is or should be actively pushing. In oneaspect, the labor assistance system 100 is initially positioned to bespaced from or only in touching engagement with the patient 10 withoutcreating pressure when the patient 10 is not experiencing a contraction.As a contraction occurs or the patient 10 pushes, the perianal tissues38 will tend to protrude thereby engaging the system 100 with a pressurethat can be felt by the mother through tactile or haptic feedback and/orsensed by the push evaluation system 615. With continued pressureapplied by the user to the grip 106 and/or the inner surface 132 of thelabor assistance system 100, the patient 10 can feel increasing tactilepressure from the perianal support member 102 against which to focus herpushing effort and direct the force of her pushing.

The extent of tissue deformation surrounding the anal orifice 26 whenthe labor assistance system 100 is applied is a function of the patientanatomy, the amount of pushing force exerted by the patient 10, and theamount of compressive force applied in the direction of arrow A4 throughthe grip 106 during application of the system 100. As shown in FIG. 1,the maximum extent of perianal tissue engagement inwardly on the patient10 in the sagittal plane is shown by the line 645. In one aspect, it iscontemplated that pressure applied in the direction of arrow A4 movesthe anal orifice 26 inwardly 1 cm to 3 cm. The compression elements 116,124 exert tension forces generally in the direction of arrows A5 and A6,respectively. The compression elements 116, 124 are substantially rigidmembers capable of transmitting compressive forces to the perianalsupport member 102 and the perianal tissues 38. The compressive forcesA5 and A6 are transmitted by substantially rigid compression elements116, 124 and ultimately to the contact surface 104 to apply supportand/or pressure to the perianal tissues in the direction of arrow A4. Itwill be appreciated that the lateral components of compressive forcesapplied in A5 and A6 help to maintain the position of the perianalsupport member 102 as well as tending to maintain the access cavity 136in an open position. It will be understood that while compressionelements 116, 124 are sufficiently rigid to transmit compressive forcetoward the contact surface 104, in one embodiment they are flexible, atleast laterally, to bow or bend in response to forces applied by thebuttocks 16, 17.

As shown in FIG. 1, a distance D2 between the anal orifice 26 and thebuttocks crown 16 is less than a distance D3 between a distal end 670 ofthe compression member 116 and the anal orifice 26. Thus, tensionapplied to the grip 106 is transferred through the substantially rigidcompression elements 116, 124 to exert a compressive force on thecontact surface 104 in the direction of arrow A4. In other embodiments,the distance D3 may be greater than the distance D4 (e.g., as shown inFIG. 15). It will be appreciated that with the illustrated embodiment,the user may maneuver the grip 106 to reposition the perianal supportmember 102 and adjust the compressive force applied through the grip 106to the contact surface 104 by decreasing or increasing the force appliedthrough the grip 106 in the direction A4 toward the patient 10.

The extent of tissue deformation surrounding the anal orifice 26 is afunction of the patient anatomy and of the amount of compressive forceapplied during application of the labor assistance system 100. In oneaspect, the health care provider makes initial contact with anal orifice26 and then applies pressure in the sagittal plane (generally toward thepatient's head) to advance the device 1 cm to 3 cm. This advancement ofthe device approximately 1 cm to 3 cm compresses the perianal tissue andthereby supports the tissue to inhibit distention as the patient 10pushes during the birthing process. It will be appreciated that with theillustrated embodiment, the user may reposition the device and adjustthe compressive force applied through the grip 106 and the compressionmembers 116, 124 to the contact surface 104 by adjusting his or hergrasp on the grip 106 to adjust the strength and directionality of forceand/or pressure applied through the contact surface 104.

In an alternative approach, the contact surface 104 is positioned inengagement with the anal orifice 26 with little if any compressive forceapplied to deform the perianal tissue 38. The perianal support member102 is then manually maintained in position using the grip 106 asdescribed above. With this technique, the labor assistance system 100will resist movement of the device in a direction generally away fromthe patient's head and will thereby support the perianal tissue tomaintain its position. In a further feature, the push evaluation system615 may indicate outward pressure on the perianal tissue to providefeedback to the patient 10 and/or other users on successful pushingduring contractions.

Still referring to FIGS. 1 and 2, with the system 100 in position, auser may position one or both hands within the access cavity 136extending into the gluteal clef 13. In this manner, the hands may bebelow the lowest portion of the vaginal opening 11 as the head of thebaby 12 passes out of the vagina. Thus, the hand within the accesscavity 136 is positionable less than 1 cm from the mother's vaginalopening or perineum so the healthcare provider may support the head ofthe baby as is it is being born. As shown in FIG. 2, the position of theanterior edge 112 of the perianal support member 102 also allows accessto the tissue immediately posterior to the vaginal opening 11 in theevent an obstetric maneuver, such as an episiotomy, manual manipulationof the fetus, etc., is necessary. In some instances, the anterior edge112 of the perianal support member 102 may be curved or concave to allowbetter access to the vaginal opening 11 while the labor assistancesystem 100 remains in position against the perianal tissues. Further, asdiscussed above, in some instances, the perianal support member 102 canbe quickly repositioned or removed, an obstetric maneuver can beperformed, the perianal support member 102 is repositioned in asupporting position adjacent the anus, and its position can bemaintained by manually handling the grip 106.

Additionally, in the illustrated embodiments, the perianal supportmember 102 of the labor assistance systems is sized and positioned withrespect to patient 10 to allow for the passage of a child through thebirthing canal during childbirth. The labor assistance system 100 ispositioned on the patient 10 such that the perianal support member 102does not extend along the patient midline 108 in the gluteal cleft 13with the potential for interference with the birthing process, butinstead extends substantially laterally from the patient's midline(e.g., the compressive members 116, 124 extend laterally from themidline axis 108). It is contemplated that the perianal support member102 may be placed to support more or less of the external perineumregion located between the anal orifice 26 and the vaginal opening 11depending on the user's judgment and the progress of the child birthingprocess. Still further, it is contemplated that an exemplary laborassistance device having an elongated anterior to posterior width W2 (asshown in FIG. 3) may be positioned to support at least a portion of theperianal tissue and the vaginal tissue during the labor process. In someembodiments, the anterior edge 112 of the perianal support member may becurved toward the posterior edge 110 (e.g., having a concave profile) toallow for greater access to the vaginal opening 11 and provide ampleroom for the baby 12 to crown. It is anticipated that the system 100will be repositioned posteriorly away from the vaginal opening prior todelivery of the child through the vaginal opening.

FIGS. 16A and 16B illustrate cross-sectional views of a patient 10 inthe sagittal plane taken along the lines 16-16 shown in FIG. 2. FIG. 16Aillustrates the perianal support member 102 positioned against thepatient 10, and FIG. 16B illustrates the perianal support member 190(described above in relation to FIG. 9A) positioned against the patient10. In FIG. 16A, the labor assistance system 100 is shown held by a userU and positioned against the perianal region 38 of the patient 10. Inother instances, the labor assistance system 100 may be secured to thepatient 10 by means of securing members and anchor pads, as describedabove in relation to FIGS. 2B and 2C. For example, the perianal supportmember 102 may be secured to the patient 10 in a manner to applypressure to the perianal and/or anococcygeal regions by securing memberssubstantially similar to the securing members 149 a and anchor padssubstantially similar to the anchor pads 149 b described above inrelation to FIGS. 2B and 2C. Such securing members and anchor pads arenot shown in FIG. 16A due to the difficulty of illustrating such anembodiment in the depicted view.

In FIG. 16A, the perianal support member 102 is positioned with thecontact surface 104 in contact with the anal orifice 26. In oneinstance, the user U holds the grip 106 to position the perianal supportmember 102 against the perianal region 38 at an angle and withsufficient pressure to assist in shortening the second stage of labor.As shown in FIG. 16, uterine contractions and the patient's pushingforce may act in the direction of an arrow A7, directing the baby 12downwards but not necessarily toward the vaginal opening 11. The baby 12is shown in a downward position with a baby's head 700 contacting thecervix 705. As the baby 12 progresses through the birth canal, themother's anatomy assists in guiding the baby 12 along an optimal pathtoward the vaginal opening 11. For example, a sacrum 710, and, inparticular, a coccyx 715, can provide an internal brace or scaffoldingto provide counter pressure in the direction of an arrow A8 that canguide and/or shift the exit trajectory of the baby 12 toward the vaginalopening 11 in the direction of arrow A11 as the patient 10 pushes thebaby 12 in the direction of the arrow A7.

Similarly, in some instances, the labor assistance system 100 may beused as an external guide or brace that provides counter pressure alongthe contact surface 104 to help guide the baby 12 along a desired paththrough the birth canal and toward the vaginal opening 11. Inparticular, the labor assistance system 100 can act as a sacralextension member or anococcygeal support member configured to providecounter pressure in the anococcygeal region (i.e., the region betweenthe anus and the coccyx of the patient 10) in the direction of an arrowA9 against the pushing forces acting in the direction of the arrow A7.The contact surface 104 of the labor assistance system 100 can act as arelatively firm and selectively yielding external scaffolding thatprevents the patient's pushing force from driving the baby's head 700 ina direction away from the ideal exit path towards the vaginal opening11. For example, the patient's pushing force may direct the baby's head700 towards the posterior of the patient 10 (e.g., towards the posteriorrectal hiatus or rectum 36) instead of more anteriorly towards thevaginal opening 11. The sacrum 710 provides a natural guide or internalscaffold that assists in redirecting the baby's head 700 towards thevaginal opening 11. Like the sacrum 710, the labor assistance device 100can act as a physical guide or external scaffold against theanococcygeal region that assists in redirecting the baby's head 700towards the vaginal opening 11, especially once the baby's head 11 hasdescended past the sacral promontory 715. Unlike the sacrum 710,however, which is relatively stationary within the patient 10, the laborassistance system 100 can act as a dynamic guide to assist the baby'sexit from the birth canal. In particular, as labor progresses and thebaby's head 700 descends through the birth canal, the user may adjustthe direction and strength of the counter pressure applied through thelabor assistance system 100 against the anococcygeal and perianalregions by changing the strength and directionality of his or her graspon the grip 106. Thus, the user may change the angle A9 as the angle A7changes with the progression of labor to best guide the baby's head 700through the birth canal.

In FIG. 16B, the perianal support member 190 is shown positioned againstthe perianal region 38 of the patient 10. In particular, the perianalsupport member 190 is positioned with the contact surface 192 in contactwith the anal orifice 26, and the focusing pressure element 200positioned against the perineum between the anal orifice 26 and thevaginal orifice 11. In one instance, the user U holds the grip 106 toposition the contact surface 192 and the focusing pressure element 200against the perianal region 38 (e.g., against a nerve or nerve bundle ornerve plexus 725 that may stimulate the patient's urge to push) at anangle and with sufficient pressure to assist in shortening the secondstage of labor. In some embodiments, the user U may observe the positionof the marker 205 in relation to the patient's anatomy (e.g., the analorifice 26) to appropriately position the focusing pressure element 200against the patient 10.

In embodiments having a clear or translucent contact surface 192 (or102), the user U may observe, mark (on the inner surface 196 or 132),and/or measure the extent of tissue distention against the contactsurface 192 or 102 upon initial placement of the device, and thenobserve, mark (on the inner surface 196 or 132), and/or measure theextent of tissue distention against the contact surface 192 or 102 afterthe change of pressure on the contact surface due to the voluntary orinvoluntary contractions of labor. The difference between the twomeasurements or the distance between the two markings may suggest theextent of the pressure changes occurring in the labor process and mayserve as an indication of the progress of labor.

As shown in FIG. 16B, the application of counter pressure in thedirection of arrow A10 through the contact surface 192 and/or thefocusing pressure element 200 may augment or spur the patient's pushingforce and aid the descent of the baby 12 in the direction of arrow A11toward the vaginal opening 11. As labor progresses and the baby's head700 descends through the birth canal, the user U may adjust thedirection and strength of the counter pressure applied through perianalsupport member 190 and/or the focusing pressure element 200 by changingthe strength and directionality of his or her grasp on the grip 106.Thus, the user U may change the angle A10 as the angle A11 changes withthe progression of labor to best guide the baby's head 700 through thebirth canal.

In use, the user can position the patient 10 to expose the perianalregion and vaginal opening 11. Referring now to FIG. 17, there is ashown a flow chart illustrating a method of utilizing a labor assistancesystem according to one aspect of the present disclosure to manage amother's labor process to reduce the duration of second stage labor andincrease the incidence of a vaginal delivery without increasing tissuedamage to the mother. In general terms, the method includes applying atactile or haptic feedback device (e.g., the labor assistance system100) in engagement with the perianal tissue and monitoring theprogression of labor during the second stage.

With respect to FIG. 17, in some instances, the method begins at step800 by determining whether the expecting mother has previously delivereda child by a vaginal delivery. If the answer to this inquiry is yes,then at step 802, the progress of labor is monitored to determine iflabor is progressing as desired at step 804. In one instance, theprogression of labor can include the amount of movement of the childtoward the vaginal opening over a given a period of time. In anotherinstance, the progression of labor can include shortening or thinning ofthe cervix, the amount of cervical dilation, assessment of fetalposition and/or descent (e.g., via digital assessment inside the vagina,via manual palpation of the abdomen, via visual observation, or viaimaging), and the amount of movement of the child toward the vaginalopening in comparison to the number of contractions or successful pushesthe mother has experienced. The determination of the progression oflabor may be made by a healthcare provider monitoring the patient or byan electronic monitoring system receiving one or more inputs indicativeof labor progression such as the strength and/or number of contractions,effective pushes, and movement of the child within the mother and/oroverall time of labor. As long as labor is progressing as desired, themethod continues with monitoring the progress of labor.

If labor is not progressing as desired in step 804, then the methodprogresses to the application of a tactile feedback device (TFD) in afirst tactile position at step 806 which could include devices similarto any of the labor assistance system embodiments described above or anyother device configured and applied to provide perianal tactilesensation to the patient. In some embodiments, the TFD may also supplyhaptic feedback to the user that is indicative of the extent of pressureapplied on the TFD. A first tactile position can include applying a TFDin a pressure inducing and tissue compression engagement at a firstpressure threshold, engagement with the perianal tissue without pressureinducement or tissue compression, or positioning adjacent the perianaltissue sufficiently close such that during a push by the mother, theprotrusion of soft perianal tissue will engage the TFD to provide atactile sensation to the mother. In some instances, the user mayposition the TFD in the first tactile position to contact the patient 10only when the patient 10 is experiencing a contraction, as observed bythe user or indicated by the electronic monitoring system. Once the TFDis positioned in the desired first tactile position, the method includesthe step at 812 of maintaining the TFD in contact against the mother inthe first position.

During initialization of the method in step 800, if it is determinedthat the mother has not previously had a successful vaginal delivery orhas previously undergone a Cesarean section child delivery procedure,the method continues to step 810 where a TFD is applied in a firsttactile position to provide perianal tactile sensation to the mother. Ofcourse, use of the methods and devices described above can be applied toall patients; however, it may be desirable in some situations to limituse of the labor management devices and techniques to those patientsmostly likely to benefit from the added attention and treatment. In someinstances, the method omits the steps 800-806 and commences at step 810with the application of the TFD against the patient 10 during the secondstage of labor. As described above, a first tactile position can includeapplying the TFD in a pressure inducing and tissue compressionengagement at a first pressure threshold, engagement with the perianaltissue without pressure inducement or tissue compression, or positioningadjacent, but spaced from, the perianal tissue in a sufficiently closearrangement such that during a push by the mother, the protrusion ofsoft perianal tissue will engage the TFD to provide a tactile sensationto the mother. Once the TFD is positioned in the desired first tactileposition, the method includes the step at 812 of maintaining the TFD tothe mother in the first position in any suitable manner, including thetechniques disclosed herein of a user grasping the grip 106 and applyingpressure through the perianal support member 102 against the patient 10.

After the TFD is positioned, the method of using the TFD to manage amother's labor continues at step 814 by monitoring the progress oflabor. In one instance, the progression of labor can include shorteningor thinning of the cervix, the amount of cervical dilation, and/or theamount of movement of the child toward the vaginal opening over a givena period of time. In another instance, the progression of labor caninclude the amount of movement of the child toward the vaginal openingin comparison to the number of contractions or successful pushes themother has experienced. In some instances, the TFD may include acounting component to track the number of successful pushing episodesexperienced by the device. In some instances, as described above, theTFD may include a haptic feedback component to monitor the pressureapplied against the device (e.g., the contact surface) by the patient.As described above, the determination of the progression of labor may bemade by a healthcare provider monitoring the patient or by an electronicmonitoring system receiving one or more inputs indicative of laborprogression such as the number of contractions, effective pushes, andmovement of the child within the mother and/or overall time of labor. Aslong as labor is progressing as desired in step 816, the methodcontinues with monitoring the progress of labor in step 814.

If labor is not progressing as desired in step 816, then the methodprogresses to modifying the position of the TFD at step 818 to move theTFD to a second tactile position on the mother to thereby increase thetactile sensation and/or to change the degree of haptic feedback for themother, which may improve her ability to effectively push the babytowards the vaginal opening by supplying a tactile focus point againstwhich to push and/or by providing an external scaffolding or sacralextension member that supports the anococcygeal region tissues(including, for example, the posterior pelvic floor tissues) to guidethe baby's head through the birth canal towards the vaginal opening.Similarly, the monitoring of the labor process also takes into accountthe administration of sensory numbing medications administered to themother at step 820. As will be appreciated, the application of numbingmedications, including spinal epidurals, orally administered painrelievers and intravenously injected pain relievers, may significantlyreduce the mother's ability to feel pain along with tactile sensation inthe perianal tissues. As a result, the method of managing the laborprocess advances to step 818 to increase the amount of tactile sensationapplied to the perianal tissues. In some instances, the user maycoordinate this repositioning of the TBD to apply more tactile sensationand/or to change the degree of haptic feedback against the mother withthe mother's contractions. Thus, the user may gradually increase thepressure applied by the TBD in sync with the increase in intrauterinepressure due to contractions. In other instances, the user may decreasethe pressure applied by the TBD in sync with the increase inintrauterine pressure due to contractions, particularly if labor isprogressing as desired

In one aspect, in order to increase tactile sensation at step 818, theTFD is moved to a second tissue engaging position where the amount ofpressure applied to the perianal tissue is increased compared to thefirst tactile position. In an exemplary embodiment, the TFD includes apressure indication mechanism that provides feedback to the individualmoving the device about how pressure is being applied, or if thepressure is increasing from the first position, as the TFD is moved tothe second position against the perianal tissues. In another exemplaryembodiment, the TFD includes a push evaluation system (e.g., the pushevaluation system 615 shown in FIG. 15) that provides feedback to theindividual moving the device about the strength, directionality, and/oreffectiveness of the mother's pushing effort. In an alternative form,the healthcare provider applies inward (toward the anus) movement of theTFD while receiving feedback from the mother concerning her ability tosense the increased tactile sensation. Once the mother indicates adesired level of tactile sensation, the healthcare provider (or thepatient in patient manipulated embodiments) maintains the device in thesecond position at step 822.

As will be appreciated, the process of monitoring labor in step 814 andincreasing the tactile sensation (or managing the labor process todecrease the tactile sensation if the mother experiences excessive painor is pushing too hard) can be repeated multiple times throughout thelabor process to manage a balance between causing pain/injury to themother and provides the mother with a tactile sensation to push againstto generate more effective pushes with increased movement of the childinto and through the birth canal. More specifically, at step 830, tissueadjacent the TFD is monitored to avoid applying too high a pressure onthe tissue for too long of a time period. Thus, in step 832 if it isdetermined that the current position of the TFD may cause tissue injury(e.g., to either the mother or the baby), then in step 834 the TFDdevice can be moved to reduce the pressure on the perianal tissue orincrease spacing from the vaginal orifice. In one embodiment, the TFDincludes a mechanism for alerting the user to an over pressure situationand this mechanism can provide feedback on the force exerted on theperianal tissue.

In embodiments employing pressure detecting systems, uterine contractionmonitors, or push evaluation systems (e.g., in the grip 106) todetermine whether a suitable pressure is being applied to the deviceand/or whether the patient's pushing force is sufficient, the user mayvisually observe the grip or may be able to identify by tactile feedbackwhen a suitable pressure is applied by and/or to the labor assistancesystem 100. If more pressure is desired as indicated by the pressuredetecting systems, the push evaluation systems, the uterine contractionmonitors, and/or observation, then the user may provide additionalpressure through the labor assistance system 100. In embodiments havingdevice adjustment elements (e.g., such as a sufficiently long grip 106)that may be manipulated by the patient, the patient may adjust thepressure applied by the system 100 based on self-assessment or feedbackfrom the various monitoring systems or healthcare professionals.

In some instances, the labor assistance systems described herein thatare configured to apply an upward pressure in the pelvic regions may beused in combination with a child birth assisting system that isconfigured to apply downward pressure in the abdominal region. Forexample, in some instances, a labor assistance system may be positionedagainst the patient's perianal region in combination with a child birthassisting system positioned around the patient's abdomen (e.g., abovethe uterus). Both systems may be arranged and configured to work inconcert to decrease the duration of the second stage of labor byassisting the patient's efforts to push the baby through the birthcanal.

FIG. 18 illustrates an exemplary childbirth assisting system accordingto one embodiment of the present disclosure. In the pictured embodiment,the child birth assisting system comprises an expandable pneumaticgirdle as described in U.S. Pat. No. 5,871,499, filed Apr. 25, 1997,titled “Child Birth Assisting System,” which is incorporated byreference in its entirety. As shown in FIG. 18, a childbirth assistingsystem 900 includes an automatically synchronized expandable pneumaticgirdle 902 configured to externally augment the secondary force of labor(e.g., the forces produced by the increase of intra-abdominal pressurethrough voluntary contractions of the abdominal muscles and diaphragm,as opposed to the primary force of labor produced by the increase ofintrauterine pressure produced by involuntary contractions of theuterus). FIG. 18 is a block diagram of the childbirth assisting system900 including a patient 10, the abdominal girdle 902, a controller 904,and a uterine contraction monitor 906. FIG. 18 illustrates a closed loopsystem using patient response and rule-based decision making methods toachieve operator specified responses. The device is a pneumatic closedloop system which is composed of the abdominal girdle 902 and thecontroller 904. The controller 904 possesses five main functions: (1)Receiving the uterine activity data from the uterine contraction monitor906 and detecting the onset and offset of contractions; (2)Synchronizing the girdle pressure with the contraction, increasing thegirdle pressure at the onset of contraction and decreasing it at theoffset of contraction; (3) Adjusting the girdle pressure automaticallyto obtain the intrauterine pressure at a preset level; (4) Displayinginformation, including girdle pressure; and (5) Setting an alarm oralert system for abnormal situations. The uterine contraction activitycan be monitored either externally (e.g., using an externaltocodynamometer) or internally (e.g., using an intrauterine catheter) bythe uterine contraction monitor 906. In alternate embodiments, thesystem may operate on an open loop principle which comprises amodification of functions 2 and 3 listed above. In the open loop system,the application and release of girdle pressure need not rely onintrauterine pressure. Instead, application of pressure to the girdlewill be triggered by detection of contraction pressure by the externaltoco sensor only, and only after a pre-determined threshold pressure isattained and held for a specified period of time.

FIG. 19 illustrates the abdominal girdle 902 according to one embodimentof the present disclosure. The girdle 902 is formed of two basiccomponents: the belt 910 and the bladder 912. The design of the beltrequires two considerations. The inner lining must be soft andcomfortable to the mother while the outer lining must have high tensilestrength so that it can be tightly secured around the mother to keep thebladder inflation pressure downward against the abdomen. The belt 910may be formed from polyvinyl chloride (PVC) or an elastomer-coatedfabric, such as polyurethane-coated nylon. For the patient's comfort,the interior lining of the belt which comes in contact with the skinshould be a soft fabric, such as the loop material of a hook-and-loopfastener, velour, woven fabric such as cotton or nylon, netting, or acombination of materials including a laminate. The choice of materialswill depend on the integration of the bladder. For example, the beltcould serve as the reinforced lining to the bladder, or it could be partof the bladder. An elastomer coating on outer layer of the belt may beadded to prevent the fabric from stretching, or the outer surface may benon-stretch cotton fabric or surgical tape. In one version illustratedin FIG. 5A, the belt is originally formed in two layers 914 and 916 sothat the bladder 912 may be inserted between the layers. (Layer 914represents the outer PVC layer and layer 916 represents the innerfabric-lined layer.) The layers may be sealed together after the bladderis inserted to firmly retain the bladder at a fixed position within thebelt. The sealing welds 918 are indicated as dashed lines.Alternatively, the bladder 912 may be floating, sealed to only one ofthe two layers of the belt, or unattached to either layer and simplyretained between the two layers once they have been sealed together.Selection of belt configuration may be made based upon pressure transferefficiency, with the floating bladder version having demonstratedimproved pressure transfer in prototypes of the invention. The choice ofmaterial of which the belt is made will depend upon whether the bladderis attached or floating.

FIG. 20 illustrates another exemplary abdominal girdle 920 in which theinner and outer layers 914′ and 916′ are sealed together without placingthe bladder 912′ between the layers. The bladder 912′ is held directlyagainst the mother's abdomen, with the inward force of the belt 910′providing means for maintaining the bladder 912′ in the proper location.

FIG. 21 illustrates a cross-sectional view of a patient 10 in thesagittal plane, and includes the childbirth assistance system 900 aswell as the labor assistance system 100 positioned on the patient. Inthe pictured embodiment, the patient's labor is managed using both thechildbirth assistance system 900 as well as the labor assistance system100. For example, in a closed loop system, once the controller 904detects the onset of contraction, the girdle pressure is increased atthe pre-set rate until the desired or preset intrauterine pressure isobtained. Once the intrauterine pressure reaches the preset pressure,the girdle pressure will be maintained to obtain a constant intrauterinepressure. The offset of contraction can be detected when the girdlepressure increases sharply, and the girdle pressure will be releasedupon detection of the offset of contraction. In some embodiments, theuser may apply increased pressure to the perianal tissues through thelabor assistance system 100 in the direction of arrow A9 as the girdlepressure increases in the direction of arrows A12, and may decrease theapplication of pressure to the perianal tissues through the laborassistance system 100 as the girdle pressure decreases. Thus, thechildbirth assistance system 900 and the labor assistance system 100 maywork in concert to increase the intrauterine pressure and aid the baby'sprogression through the birth canal. Whereas the childbirth assistancesystem 900 works from “above” the uterus, increasing external pressureon the abdomen to force uterine contents (e.g., the baby) downwardtoward the vaginal orifice, the labor assistance system 100 may operatefrom “below” the uterus by providing the patient with a tactile,pressure-responsive focal point for pushing against and/or providing asacral extension member. The labor assistance system 100 may also directthe added pressure on the uterus and the baby in the direction of arrowA11 toward the lower pressure area of the vaginal opening 11.

FIG. 22A illustrates a perspective view of an exemplary labor assistancesystem 950 including a perianal support member 960 according to oneembodiment of the present disclosure. FIG. 22B illustrates a side viewof the exemplary labor assistance system shown in shown in FIG. 22Aaccording to one embodiment of the present disclosure. FIG. 22Cillustrates a top view of the exemplary labor assistance system shown inFIG. 22B including exemplary securing members according to oneembodiment of the present disclosure. FIG. 23 illustrates a partialperspective bottom view of the labor assistance system 950 shown in FIG.22C applied to a patient 10 during child delivery. FIG. 24 illustrates across-sectional view of the patient 10 in the sagittal plane, andincludes the labor assistance system 950 positioned on the patient 10.

The perianal support member 960 is substantially similar to the perianalsupport member 102 except for the differences described herein. Forexample, the perianal support member 960 includes a contact surface 962extending along a midline axis 964 from an anterior edge 974 to aposterior edge 976. In the pictured embodiment, the contact surface 962is slightly curved (e.g., concave) as shown in FIGS. 22A and 22B. Asbest shown in FIG. 22B, the contact surface 962 of the perianal supportmember 960 includes areas having different radii of curvature. Forexample, in the pictured embodiment, a posterior region 978 of thecontact surface 962 adjacent the posterior edge 976 has a smaller radiusof curvature RC1 than the radius of curvature RC2 of an anterior region980 adjacent to the anterior edge 974. In other embodiments, the contactsurface 962 may be substantially straight, as shown with respect to thecontact surface 102 shown in FIG. 3). An opposing inner surface 966defines an access cavity 968. A grip (e.g., the grip 106 discussedabove) may be coupled to and extend from the inner surface 966. Theperianal support member 960 includes compression elements 970 and 972that flank the contact surface 192. In some embodiments, the compressionelements 970, 972 are integral extensions of the contact surface 962. Inother embodiments, the compression elements 970, 972 are coupled to thecontact surface 962. The compression elements 970, 972 may extend equaldistances from the contact surface 962, as shown in FIG. 22A, or theymay extend unequal or different distances from the contact surface 192.

The compression elements 970, 972 meet the contact surface 962 to form asaddle-shaped structure. Each compression element 970, 972 is shaped andconfigured to include a short portion 970 a (shown in FIG. 22C), 972 a,and a long portion 970 b, 972 b. As best shown in FIG. 22C, the longportions 970 b, 972 b form the anterior edge 974 and the short portions970 a, 972 a form the posterior edge 976 of the perianal support member102. This configuration enables the narrower or shorter portion of theperianal support member 960 (i.e., the shorter portions 972 a, 970 a,and the contact surface 962 adjacent those portions) to be positionedmore easily within the gluteal cleft, as shown in FIGS. 23 and 24.

In some embodiments, the perianal support member 960 is bendable alongthe axis 964. In the pictured embodiment, the perianal support member960 includes markings 144 b, which are substantially similar to themarkings 144 described above in relation to FIGS. 2B and 2C. In someembodiments, the markings 144 b comprise cutouts in the contact surface962 that facilitate the bending of the perianal support member 960. Forexample, with reference to FIGS. 23 and 24, which illustrate theperianal support member 960 positioned against the patient 10, thecontact surface 962 of the perianal support member 960 may be bent intoa slightly concave shape upon application of pressure to the contactsurface 962 (e.g., through the handle 106).

As described above, FIG. 22C illustrates a top view of the laborassistance system 950 including two securing members 982 a, 982 b thatterminate in anchor pads 984 a, 984 b. The anchor pads 984 a, 984 b areshaped and configured to be removably attached to the buttocks 14, 15(e.g., within the gluteal cleft 13) of the patient 10 (in a similarfashion as shown in FIG. 2C). In some embodiments, the anchor pads 984a, 984 b may be adhesively attached to the patient 10. In the picturedexample, the securing members 982 a, 982 b are fixedly coupled to thecompression elements 972, 970 and the anchor pads 984 a, 984 b,respectively. In some examples, the securing members 982 a, 982 binclude a first half of a releasable fastening system coupled to thecompression elements 972, 970, such as a hook and loop system or areleasable adhesive system. In the illustrated embodiment, the anchorpads 984 a, 984 b have a generally rectangular shape that is shorter inlength and wider than elongated securing members 982 a, 982 b. The shapeof the anchor pads 984 a, 984 b is shown for illustration purposes andmay take any form that is suitable for fixing to a patient or inanimateobject, as well as joining to the elongated fixation member. Each anchorpad 984 a, 984 b includes, as shown in FIG. 22C, a first side 986 a, 986b, respectively, and an opposite second side 988 a, 988 b, respectively(shown in phantom in FIG. 22C). A portion of each anchor pad 984 a, 984b includes at least a portion of the opposite second side 988 a, 988 bhaving an adhesive surface (which, in some embodiments, may besubstantially similar to the adhesive surface 642 described in moredetail with relation to FIG. 15) adapted for joining to the patient'sskin or some inanimate object. The opposing first side 986 a, 986 b(which, in some embodiments, may be substantially similar to the surface644 described in more detail with relation to FIG. 15) includes thesecond half of the fastening system, which couples to the securingmember 982 a, 982 b, respectively. In some embodiments, at least aportion of a surface of the anchor pads, whether the first sides 986 a,986 b or the opposing second sides 988 a, 988 b, includes an adhesivecoating that can fix the securing member to another object. In oneembodiment, the adhesive coating is adapted for releasably adhering to apatient's skin.

Labor assistance systems as described herein may be applied to patientsfor a variety of reasons including, alone or in combination, any of thefollowing: a) shortening the second stage labor by providing a pushfocal point to enhance the effectiveness of contractions in advancingthe baby down the birth canal, b) reducing the necessity of Cesareansection births by encouraging and monitoring, via pressure feedback, theeffectiveness of contractions to generate a pushing effect on the babyto move it toward the vaginal opening as sensed by pressure exerted onthe perianal tissue, c) assisting the baby's progression through thevaginal canal by providing an external scaffolding using an anococcygealsupport device or sacral extension member, d) covering all or most ofthe anal orifice and thereby providing defecation control, e)suppressing hemorrhoid development and/or advancement of existinghemorrhoids, f) supporting internal and external tissues to inhibitdamage such as anal sphincter damage and lacerations, and g) deliveringpost-delivery therapeutic treatments, such cooling treatments, forexample.

In one embodiment, the labor assistance system 100 (and/or the laborassistance system 950) is formed of biocompatible material suitable forcontact with human tissue. Moreover, in one embodiment, the system isprovided sterile in a package for single use application on a patient,although reusable devices according to the present teachings are alsodisclosed in the present description. In the single use type ofembodiment, the system is cost effectively manufactured such that it isdiscarded after use. For example, the system 100 is formed by of asubstantially rigid polycarbonate material. In one aspect, the system100 is injection molded to substantially its final form (e.g., V-shapedform with the grip 106). In some embodiments is contemplated that grip106 may be riveted, snapped or otherwise fixedly attached to the contactsurface 104 and compression elements. Still further, in a differentembodiment, the grip 106 is passed through a channel or other openingassociated with the compression elements to removably join the grip 106to the perianal support member 102.

It is contemplated that in other embodiments, the perianal supportmember 102 and the grip 106 are formed by compression molding, transfermolding, reactive injection molding, extrusion, blow molding, casting,heat-forming, machining, deforming a sheet, bonding, joining orcombinations thereof. In other embodiments, suitable materials for theperianal support member 102 and the grip 106 include polymers, metals,ceramics or combinations thereof. The materials can be or include aloneor in combination: hard solids, soft solids, tacky solids, viscousfluid, porous material, woven fabric, braided constructions, ornon-woven mesh. Examples of polymers include polyethylene, polyester,Nylon, Teflon, polypropylene, polycarbonate, acrylic, PVC, styrene,PEEK, etc. Examples of ceramics include alumina, zirconia, carbon,carbon fibers, graphites, etc. Examples of suitable metals includetitanium, stainless steel, cobalt-chrome, etc.

It is contemplated that in some embodiments, the perianal support member102 and grip 106 can be sterilized by known techniques such as ethyleneoxide gas, gas plasma, electron-beam radiation or gamma radiation. Suchmaterials are available from various suppliers such as 3M. In a similarmanner, the securing members or anchor pads may be formed of hook andloop fastening systems available from 3M. Adhesive fixation systems maybe adhesive a Rayon woven tape on a liner (1538L from 3M). The tape mayinclude liners to prevent premature tape adhesion. In one embodiment,for example, the liners include a cut between the midline end of theanchor pad and the lateral end. During initial placement, the system ispushed against the anus with a firsthand. The opposite hand spreads thebuttocks away from the device while the first hand pushes the perianalsupport member to get further compressive penetration in the glutealcleft. The hands are switched and the steps are repeated on the oppositebuttocks. After positioning the system, the liners adjacent the anchorpads are sequentially removed and adhered to the medial portion of thebuttocks for provisional positioning of the device. Once the device isprovisionally positioned, the first lateral liner is removed and withpressure applied to the device, the lateral tape segment is adhered tothe patient in a final supporting position to supply compressive forceto the device. This step is repeated on the opposite side for finalfixation.

The present invention also contemplates a kit that includes one or moreof the components described above provided in a package. In oneembodiment, the kit includes at least a sterilized labor assistancesystem. In another aspect, the kit includes a push evaluation system(including securing members and anchor pads) as described above. Instill another aspect, the kit includes a childbirth assisting system asdescribed above. In yet another aspect, the kit includes removable grip.In some embodiments, the push evaluation system may be preassembled withthe labor assistance system as shown in FIG. 15 or may be providedunassembled. In the unassembled kit, a health care provider can removethe perianal support member, grip, and push evaluation system from thepackaging and assemble the labor assistance system with or withoutconnection to the childbirth assisting system. In still a furtherembodiment, the kit includes a treating compound to apply to thepatient. In one such embodiment, the treating compound is provided in aseparate package. In an alternative embodiment, the treating compound isapplied to or incorporated into the labor assistance system on thecontact surface of the perianal support member.

In addition to perianal support during labor, devices and methodsdisclosed herein provide support to the pelvic floor during anintrapartum period, for example during stage II labor. The pelvic floor,sometimes referred to as the pelvic diaphragm, includes the inferiorborder of the pelvic cavity defined between the lower opening of thepelvic girdle. The pelvic floor has two openings: the anteriorurogenital opening through which the urethra and vagina pass and theposterior rectal opening through which the anal canal passes. The pelvicfloor, the sacrum, and the coccyx cooperate to facilitate birth byresisting the downward descent of the presenting part of the baby, andthereby helps the baby to rotate forward to navigate through the pelvicgirdle and exit the vaginal opening.

According to embodiments of the present disclosure, an intrapartumpelvic floor support device provides support to one or more muscles ofthe pelvic floor to assist in preventing birth-related traumas to thepelvic floor, such as pelvic floor incompetence or dysfunction(over-stretching of pelvic floor muscles, ligaments and tendons), organprolapse resulting from the over stretching, and incontinence secondaryto pressure and stretching exerted on the bladder and bladder neck. Inone aspect, the intrapartum pelvic floor support device or anococcygealsupport device is provided to apply pressure to the skin extending fromthe perianal region to the coccyx that overlies the pelvic floor tothereby push against and support the internal pelvic floor tissues.Support of the anococcygeal region may increase or lengthen thescaffolding provided by the anatomical pelvic tissues (including, forexample, the pelvic floor musculature, the sacrum, and the coccyx) bylengthening or increasing the area of counterpressure applied to thepresenting part of the baby as it descends in the direction of theposterior rectal hiatus, thereby encouraging the baby to turn in thedirection of the anterior urogenital hiatus (i.e., the vaginal opening).Support of the posterior pelvic floor by the devices disclosed hereinmay also assist in reducing injury to the mother from pelvic floordistension that can result from force applied by the baby during labor.

FIG. 25 illustrates a partial cross sectional bottom view and stylizeddepiction of a patient 10's anatomy. In FIG. 25, the patient 10 is shownin partial cross section to illustrate a portion of various muscles ofthe pelvic floor. Muscles of the pelvic floor include thebulbocavernosus muscles 80, the ischiocavernosus muscles 82 near thevaginal opening 11, the transverse perineal muscles 84, the externalanal sphincter muscle 86 near the anal orifice 90, and the levator animuscle 88. As illustrated in FIG. 25, the muscles of the pelvic floorare deeper within the patient 10 than the skin tissues or, in otherwords, the skin above the pelvic floor is superficial (or superior withrespect to the outside of the body) to the muscles of the pelvic floorlisted above. In addition, the muscles of the pelvic floor aresuperficial (or superior with respect to the outside of the body) to thepelvic bones. Also illustrated in FIG. 25 are the gluteus maximusmuscles 89.

FIGS. 26A-31A illustrate an intrapartum pelvic floor support device oranococcygeal support device 1000 positioned on a patient 10 according tovarious embodiments of the present disclosure. FIG. 26A illustrates abottom view of the exemplary intrapartum anococcygeal support devicepatient according to one embodiment of the present disclosure. FIG. 26Billustrates a top view of the exemplary intrapartum anococcygeal supportdevice patient shown in FIG. 26A according to one embodiment of thepresent disclosure. FIG. 26C illustrates a perspective view of theexemplary intrapartum anococcygeal support device patient shown in FIG.26A according to one embodiment of the present disclosure. FIG. 26Dillustrates a side view of the exemplary intrapartum anococcygealsupport device patient shown in FIG. 26A according to one embodiment ofthe present disclosure. In some instances, the anococcygeal supportdevice 1000 provides a physical or tactile sensation against thepatient's skin that acts as a focal point against which the patient candirect her pushing effort during labor. In some instances, theanococcygeal support device 1000 may, for example by covering the analorifice 70, increase the patient's willingness to push. In someinstances, the anococcygeal support device 1000 supports the pelvicfloor tissues and acts in concert with the pelvic floor tissues to turnthe baby in the correct direction toward the vaginal orifice 11.

As illustrated in FIG. 26A, the anococcygeal support device 1000 may bepositioned over one or more muscles of the pelvic floor, for example atleast a portion of bulbocaervnosus muscles 80, at least a portion of theischiocavernosus muscles 82, at least a portion of the transverseperineal muscles 84, at least a portion of the external anal sphinctermuscle 86, and at least a portion of the levator ani muscles 88 duringlabor. As illustrated, the anococcygeal support device 1000 extends oversubstantially all of the levator ani muscles 88, the transverse perinealmuscles 84, and the external anal sphincter 86.

In the embodiment shown in FIGS. 26A-26D, the anococcygeal supportdevice 1000 includes first and second compression elements 1001 and 1002that extend laterally away from a central compression element 1003. Asshown best in FIGS. 26B and 26C, the central compression element 1003extends longitudinally along the center of the anococcygeal supportdevice 1000 from an anterior portion to a posterior portion. In someembodiments, the anococcygeal support device 1000 is relatively flexibleto conform to the contours of the patient's anatomy while retaining therigidity necessary to apply force to the anococcygeal and/or perianalregion.

In one embodiment, as shown best in FIG. 26C, the anococcygeal supportdevice 1000 may be contoured in multiple directions to at leastpartially anatomically conform to the patient 10. For example, thecentral compression element 1003 may be formed to fit in the glutealcleft 13. The first compression element 1001 has an inner surface 1004and an outer surface 1005. The inner surface 1004 of the anococcygealsupport device 1000 is the surface that faces and comes into contactwith skin of the buttocks 14 of the patient 10 (and, in embodiments, hasan adhesive 1006 to adhere to the skin, as shown in FIG. 26C). The innersurface 1004 is partially concave so that it may receive the buttock 14in a manner that is anatomically conforming, as illustrated in FIG. 27.In the pictured embodiment, the anococcygeal support device 1000includes ribs 1003 a that extend from the inner surface 1004 toward thecentral compression element 1003. The spines 1003 a may be shaped as anyof a variety of structures that are configured to provide structuralsupport to the central compression element 1003. The ribs 1003 a conveya force from the inner surface 1004 to the central compression element1003. The adhesive coating 1006 As best shown in FIG. 26C, the outersurface 1005 is the surface that faces away from the patient 10 and isconvex so that the outer surface 1005 follows the profile established bythe concavity of the inner surface. In similar manner, the secondcompression element 1002 has inner and outer surfaces that conform to acurvature of the buttock 15 toward its crown, such as is illustrated inFIG. 27. In some embodiments, as shown in FIG. 26C, at least a portionof the inner surface 1004 includes an adhesive coating 1006 that can fixthe compression element 1001 to another object. In one embodiment, theadhesive coating 1006 is adapted for releasably adhering to a patient'sskin. In the pictured embodiment, the adhesive coating 1006 is coveredby a removable tape 1007 that acts to preserve the tackiness of theadhesive coating 1006 prior to the user removing the tape 1007 andaffixing the anococcygeal support device 1000 to another object,including, for example, the skin of the patient. In some embodiments,the adhesive coating 1006 overlies a pad-like structure that may besimilar to the anchor pads described above with relation to FIGS. 2B and2C, for example, The ribs 1003 a convey a force from portion of theinners surface adjacent the adhesive coating 1006 to the centralcompression element 1003. FIG. 27 illustrates a perspective view of theintrapartum anococcygeal support device 1000 positioned on the patient10. The side view in FIG. 27 looks from the posterior of the patient 10towards the anterior of the patient 10 that is not visible in FIG. 27.As can be seen in FIG. 27, the first and second compression elements1001, 1002 of the intrapartum anococcygeal support device 1000 includeconcave inner surfaces (e.g., inner surface 1004) that follow thecontour of the buttocks 14, 15. This results in the central compressionelement 1003 extending into the gluteal cleft 13.

In addition to the contour, the relative rigidity of the intrapartumanococcygeal support device 1000 may vary along different portions ofthe device. For example, the intrapartum anococcygeal support device1000 may have increased rigidity in the area of the central compressionelement 1003, e.g. focused at an area at and/or near the anal sphincter86 with flexibility increasing closer to the perineum of the patient 10and as the first and second compression elements 1001, 1002 extendlaterally away from the central compression element 1003. In oneexample, such as shown in FIG. 28, the variation in rigidity isaccomplished by thinning the material as it extends from the centralcompression element 1003 such that the center material is thicker thanthe lateral material found at the edges of the first and secondcompression elements 1001, 1002. Further, the configuration of thecentral compression element 1003 may be designed so as to providedifferent levels of pressure to the tissue it comes in contact with. Inone example, the central compression element 1003 may have a ridge thatfits within the gluteal cleft 13 and approximately uniformly comes intocontact with the pelvic floor tissue extending from the intrapartumanococcygeal support device 1000's anterior portion to its posteriorportion. The ridge may have a uniform height to apply uniform pressurealong the cleft, or alternatively may have an increase or decrease inheight in one or more areas to provide more or less pressure,respectively, at those points. In an alternative embodiment, the centralcompression element 1003 may have two parallel ridges and a small valleytherebetween that runs along the length from the anterior to posteriorportions of the patient 10, for example similar to that illustrated inFIG. 34B.

There are multiple ways in which the intrapartum anococcygeal supportdevice 1000 may be held in place against the patient 10. According to anembodiment, a pair of extending securing members 2010 and 2020 may beattached to top surfaces of the first and second compression elements1001, 1002 and configured to assist in holding the intrapartumanococcygeal support device 1000 in pressurized engagement with thetissue superficial to the pelvic floor (e.g., the patient 10's skin overthe muscles of the pelvic floor) such as in the areas shown in FIGS.26A-31A. The securing members may be the first half of a releasablefastening system with adhesive pads 2012 and 2022 attached to thepatient, such as a hook and loop system or a releasable adhesive system,similar to the manner described above with relation to FIGS. 2B, 2C, 9B,15, 22C, 23, and 26B-26D. A securing member 2020 may be attached to thefirst compression element 1001 at a periphery of the first compressionelement 1001 and be joined to pad 2022. In a similar manner, the secondsecuring member 2010 may be attached to the second compression element1002 at a periphery of the second compression element 1002 and be joinedto pad 2012. In some embodiment, the securing members may be elongated,flexible strips of a material. The securing members may extend outwardlyand laterally away from the central compression element 1003.

The securing members may be part of a releasable fastening system asdescribed above with respect to other embodiments. In an example, thesecuring members may be attached to respective anchor pads, for exampleadhered to skin of patient 10 superficial or superior to the gluteusmaximus muscles 89. Each anchor pad may have a generally square shapethat is shorter and wider than the securing members. The anchor pads maytake any form that is suitable for fixing to a patient or inanimateobject. The anchor pads may include a first adhesive surface adapted forjoining to the patient's skin or some inanimate object. The opposingsurface of each anchor pad may include the second half of the releasablefastening system. Instead of using the hook and loop fastenerarrangement discussed above, at least a portion of surfaces of thesecuring members may have an adhesive coating adapted for joining to afixed object. The securing members may be fixed to an inner surface ofthe first and second compression elements. At least a portion of asurface of the securing members may include an adhesive coating that canfix the securing member to another object.

In one embodiment, the adhesive coating is adapted for releasablyadhering to a patient's skin. In another embodiment, the adhesive isadapted for joining to an inanimate object (e.g., a table or aninstrument) or to itself. In this manner, the securing member can fixthe position of the intrapartum anococcygeal support device 1000relative to the operating table or other fixture near the patient 10. Insome embodiments, the securing members are formed of flexible tape.Further, while they have been described separately, in one embodiment,the securing members are formed by a continuous piece of material joinedat or near the central compression element 1003.

In an alternative embodiment, the securing members may be attached toone or more raised surfaces at the top surfaces of the first and secondcompression elements 1001, 1002. The raised surfaces may be, forexample, raised pegs that elevate the areas to which the securingmembers are attached. With the areas raised, the securing members mayclear the crowns of the buttocks 14, 15 to reach the locations of theanchor pads without interference from the crowns of the buttocks 14, 15.

With the intrapartum anococcygeal support device 1000 secured, it iscapable of applying support and pressure to one or more tissues of thepelvic floor during the intrapartum period. As illustrated, theintrapartum anococcygeal support device 1000 may provide this supportand/or pressure without interfering with the birthing canal or vaginalopening 11. The contoured inner surfaces of the compression elements1003, 1001, and 1002 contact the skin overlying the above-identifiedtissues. In this manner, the intrapartum anococcygeal support device1000 may non-invasively reduce and/or inhibit pelvic floor trauma. Theintrapartum anococcygeal support device 1000 is non-invasive because itis applied to the exterior of the patient 10 and is not implanted intothe patient 10. Moreover, the illustrated embodiments are not insertedinto any cavity, such as the anal orifice 90 or the vaginal opening 11.

FIG. 28 illustrates a perspective view of an exemplary intrapartumanococcygeal support device 1000′ looking from the anterior portion ofthe patient 10 towards the posterior portion of the patient 10. FIG. 29illustrates a bottom view of the intrapartum anococcygeal support device1000′ positioned on the patient 10. For simplicity of discussion, onlythose aspects of FIGS. 28 and 29 that vary from the discussion abovewith respect to FIGS. 26A-27 will be addressed. The support device 1000′is substantially similar to the support device 1000 described above withthe exception of the differences described below. The centralcompression element 1003′ has an interior surface 1004′. The interiorsurface 1004′ of the central compression element 1003′ is partiallyconvex and partially concave (as are the inner surfaces of the first andsecond compression elements 1001′, 1002′ to varying degrees) so as tofollow the anatomical curvature along the patient 10's midline axis inthe sagittal plane as the device 1000′ extends from the base of thevaginal opening 11 toward the anal orifice 90 (not shown in FIG. 27),curving upward beyond the anal orifice 90 in the posterior direction,e.g. curving upward toward the patient 10's coccyx (not shown in FIG.27).

FIGS. 28 and 29 illustrate the intrapartum pelvic floor support device1000 according to an alternative embodiment. The intrapartumanococcygeal support device 1000′ in FIG. 28 further includes a gap 1008that extends along a portion of the central compression element 1003. Asshown, in the pictured embodiment, the gap 1008 is rectangular in shape.Above the gap 1008, an anterior portion 1009 of the intrapartumanococcygeal support device 1000′ extends between or bridges between thefirst and second compression elements 1001′, 1002′. The gap 1008 mayallow for defecation or other desired access to the perianal regionduring the intrapartum period. As such, although depicted as rectangularin shape in the embodiment shown in FIG. 28, the gap 1008 mayalternatively be of any shape that is sufficient to expose the perianalregion while still otherwise generally maintaining pelvic floor supportas discussed above.

According to embodiments of the present disclosure, the intrapartumanococcygeal support device 1000 may be used in cooperation with otherdevices, such as the perianal support member 102. The gap 1008 may besized and shaped specifically so that it may receive the perianalsupport member 102, for example as illustrated in FIG. 31A. As shown, anexternal pressure surface or contact surface 104 of the perianal supportmember 102 fits within the gap 1008, for example with sufficientprecision that there is only a small distance between the inside wallsof the gap 1008 and the surfaces of the perianal support member 102 soas to avoid pinching of patient tissue. Edges of the inside walls of thegap 1008 may have a radius shape to further avoid pinching. The perianalsupport member 102 may utilize its own securing members according to oneor more of the examples described above. Alternatively, the intrapartumanococcygeal support device 1000 may not include any securing membersand instead rely upon the perianal support member 102 utilizing its ownsecuring members to thereby keep the intrapartum anococcygeal supportdevice 1000 in place as well.

FIG. 30 illustrates the intrapartum anococcygeal support device 1000according to an alternative embodiment to that discussed above withrespect to FIGS. 28 and 29. In the pictured embodiment, the intrapartumanococcygeal support device 1000″ is substantially similar to theanococcygeal support member 1000′ described above, except for thefollowing differences. In FIG. 30, instead of a gap 1008, theintrapartum anococcygeal support device 1000″ includes a recess 1008′.The recess 1008′ interrupts the first and second compression elements1001″, 1002″ from connecting each other in an anterior portion of theintrapartum anococcygeal support device 1000 (e.g., near the vaginalopening 11).

In some embodiments, the intrapartum anococcygeal support device 1000 ofFIG. 26A may be used alone, without cooperation with a perianal supportmember 102. In alternative embodiments, the recess 1008 of theintrapartum anococcygeal support device 1000′ may be sized and shaped sothat it may receive the perianal support member 102, for example so thata posterior end of the perianal support member 102 is adjacent to and incontact with a posterior end of the recess 1008. In an embodiment, theposterior end of the recess 1008′ may include one or more lockingmechanisms according to one or more of the examples given below withrespect to FIG. 28 that couple the intrapartum anococcygeal supportdevice 1000′ and the perianal support member 102 together while appliedto the patient 10.

In some embodiments, the perianal support member 102 may be held inplace with respect to the intrapartum anococcygeal support device 1000by reliance on one or more securing members alone. Alternatively, asshown in FIG. 31A, the intrapartum anococcygeal support device 1000 mayinclude one or more locking mechanisms 1010 that are designed to lockthe perianal support member 102 into place when applied into the gap1008.

FIG. 31B illustrates the exemplary locking mechanism 1010 shown in FIG.31A in closer detail according to one embodiment of the presentdisclosure. In FIG. 31B, a female member 1011 may include a blockingmember 1011 a and a tab 1011 b. In an embodiment, the female member 1011may be integrated or attached with a surface of the intrapartumanococcygeal support device 1000 near the gap 1008. A male member 1011 cattached to the perianal support member 102 may include a finger 1011 dthat, when inserted into the female member 1011, will be caught at theblocking member 1011 a to operatively couple the perianal support member102 and the intrapartum anococcygeal support device 1000 together. Aswill be recognized, in other embodiments, the female locking member 1011may alternatively be included with the perianal support member 102 andthe male member 1005 with the intrapartum anococcygeal support device1000. Exemplary locking mechanisms such as that illustrated in FIG. 31Bare further discussed in U.S. Pat. Nos. 4,946,404 and 5,577,779, both ofwhich are incorporated by reference herein in their entireties.

In another alternative embodiment, the intrapartum anococcygeal supportdevice 1000 may include a first part of a ratchet locking mechanism andthe perianal support member 102 may include a second part of the ratchetlocking mechanism. For example, the intrapartum anococcygeal supportdevice 1000 may include a finger that engages teeth in one direction,and the perianal support member 102 a corresponding gear or rack thathas teeth to engage the finger. The finger may be spring loaded so thatthe position of the perianal support member 102 may be shifted toincrease or decrease pressure applied by the perianal support member 102as compared to the intrapartum anococcygeal support device 1000.

FIG. 32A illustrates an intrapartum pelvic floor or anococcygeal supportdevice 1012 positioned on a patient 10 according to an embodiment of thepresent disclosure. The intrapartum pelvic floor support device 1012includes first and second compression elements 1013, 1015 that extendlaterally from a midline 1014. The first and second compression elements1013, 1015 have smaller lateral extensions from the midline 1014 at theanterior portion of the intrapartum pelvic floor support device 1012than at the posterior portion of the device 1012, which becomes largertowards the posterior of the patient 10. As a result, the intrapartumpelvic floor support device 1012 may engage the tissue superficial orsuperior to the levator ani muscles 88 of the pelvic floor. This may bebeneficial because the levator ani muscles 88 often endure trauma duringvaginal childbirth, and the counterpressure applied by the intrapartumpelvic floor support device 1012 during delivery may help to minimizesuch trauma by, for example, resisting tissue distention and tearing.

In some embodiments, the intrapartum pelvic floor support device 1012 iscontoured in lateral and posterior directions from the midline 1014. Forexample, FIG. 32B illustrates a partial perspective view of theintrapartum pelvic floor support device 1012. As illustrated in FIG.32B, the first compression element 1013 has a concave inner surface1013A as the first compression element 1013 extends laterally away fromthe gluteal cleft 13 that enables a contour of buttock 15 to fit withinit. The second compression element 1015 has a concave inner surface1015A as the second compression element 1015 extends laterally away fromthe gluteal cleft 13 that enables a contour of buttock 14 to fit withinit.

As further illustrated in FIG. 32C, which illustrates a side view of theintrapartum pelvic floor support device 1012, the intrapartum pelvicfloor support device 1012 may curve in the posterior direction upwardtoward the coccyx. This is illustrated by the (concave) curved surface1017 in FIG. 32C. As illustrated in FIG. 32C, the narrower side (theleft side in the pictured embodiment) of the intrapartum pelvic floorsupport device 1012 is located near the vaginal opening 11 while thewider side (the right side in the pictured embodiment) is located nearthe coccyx of the patient 10.

In an embodiment, the midline 1014 may be a ridge that fits within thegluteal cleft 13 and approximately uniformly comes into contact with thepelvic floor tissue extending from the intrapartum pelvic floor supportdevice 1012's anterior portion to its posterior portion. This ridge mayhave a uniform height configured to apply uniform pressure along thecleft. In an alternative embodiment, the midline 1014 may have a void orrecess 1016 at or near the anal orifice 90, as shown in FIGS. 32A-32C,in order to prevent or reduce the pressure applied to the perianaltissue at or near the anal orifice 90. As a result, less pressure may beapplied to the tissues at the anal orifice 90 than other contact areasof the pelvic floor. In another alternative embodiment, the midline 1014may be convex at or near the anal orifice 90 in order to provideincreased pressure to tissues at or near the anal orifice 90. As aresult, greater pressure may be applied to the tissue at the analorifice 90 than other contact areas of the pelvic floor. In anotheralternative embodiment, the midline 1014 may have two parallel ridgesand a small valley therebetween that runs along the length from theanterior to posterior portions of the patient 10, for example similar tothat illustrated in FIG. 34B as discussed in more detail below.

In some embodiments, the intrapartum pelvic floor support device 1012may be held in place against the patient 10 according to one or more ofthe embodiments discussed above with respect to the device of FIG. 26A.

FIG. 33 illustrates an intrapartum pelvic floor or anococcygeal supportdevice 1018 according to an embodiment of the present disclosure. Theintrapartum pelvic floor support device 1018 includes first and secondcompression elements 1020 and 1022, as well as a midline 1021. The firstcompression elements 1020, 1022 may each have a concave inner surface toallow a buttock's contour to fit within it at least partially. Asillustrated in FIG. 33, a posterior portion 1024 of the intrapartumpelvic floor support device 1018 is curved upward to follow the contourof the gluteal cleft 13 of a patient 10, and represents the portion ofthe intrapartum pelvic floor support device 1018 which would be placedat the posterior of the patient 10 toward the coccyx. This curvature maybe similar in principle to that discussed above with respect to FIG. 32Cand the curved surface 1017. The anterior portion 1026 follows thecontour of the gluteal cleft 13 and extends toward the vaginal opening11. The intrapartum pelvic floor support device 1018 provides pelvicfloor support by medially compressing tissue that it comes in contactwith.

The intrapartum pelvic floor support device 1018 may be held in placeagainst a patient 10 according to one or more of the embodimentsdiscussed above with respect to the device of FIG. 26A. The intrapartumpelvic floor support device 1018 may be preformed, for example by aninjection molding process, according to a pre-defined contour. Thepre-defined contour may represent a composite profile of different bodytypes, for example. Alternatively, the intrapartum pelvic floor supportdevice 1018 may have one of multiple pre-defined contours, each of whichproviding a different contour resulting in more or less pressure atparticular areas of the intrapartum pelvic floor support device 1018than the other contours.

FIG. 34A illustrates an intrapartum pelvic floor support device 1028according to an embodiment of the present disclosure. The intrapartumpelvic floor support device 1028 includes first and second compressionelements 1030, 1032 and central compression element 1034. Theintrapartum pelvic floor support device 1028 has a shape analogous tothe perianal support member 102, but differs in that the intrapartumpelvic floor support device 1028 has a different width to height ratio.For example, the central compression element 1034 is significantly wider(e.g., defined along the frontal plane, transverse to the sagittalplane) than the perianal support member 102's contact surface 104. In anembodiment, the central compression element 1034 has a widthsufficiently wide to laterally engage tissue superficial to at least aportion of the transverse perineal muscles 84 of a patient 10 whenapplied.

The central compression element 1034 may be contoured to follow thecurve of the gluteal cleft 13 of a patient 10, for example curvingupward toward the coccyx at a posterior end of the intrapartum pelvicfloor support device 1028 (e.g., an end of the device that is situatedat a proximal end of a patient 10). In an embodiment, the intrapartumpelvic floor support device 1028 may also include a flare at an anteriorportion (e.g., an end of the device that is situated at an anterior endof a patient 10). This flare may be v-shaped so as to extend towardsopposite sides of a vaginal opening 11 of a patient 10. By flaringtowards opposite sides of the vaginal opening 11, the intrapartum pelvicfloor support device 1028 may additionally provide pelvic floor supportto at least a portion of the ischiocavernosus muscles 82.

The intrapartum pelvic floor support device 1028 may be held in placeagainst the patient 10 according to one or more of the embodimentsdiscussed above with respect to the device of FIG. 26A, as well asdiscussed above with respect to FIGS. 1-3.

FIG. 34B illustrates an alternative embodiment of the intrapartum pelvicfloor support device 1028. As illustrated in FIG. 34B, instead of arelatively flat surface as in FIG. 34A, the central compression element1034 has a concave inner surface, described elsewhere as a small valley,resulting in two ridges that may engage tissue superficial or superiorto lateral muscles of the pelvic floor, such as the levator ani muscles88, the transverse perineal muscles 84, and the ischiocavernosus muscles82 to name a few examples.

FIG. 34C illustrates an alternative embodiment of the intrapartum pelvicfloor support device 1028. In FIG. 34C, the lateral width of the centralcompression element 1034 varies along the length of the intrapartumpelvic floor support device 1028, resembling a dumbbell shape as anexample. For example, the anterior portion of the intrapartum pelvicfloor support device 1028 that is placed near the vaginal opening 11(the portion of the device in FIG. 34C facing the top of the page) mayhave a first width that is relatively large in order to support thepelvic floor muscles in that region. As the central compression element1034 continues down along midline axis of the patient 10, a middleportion of the intrapartum pelvic floor support device 1028 may have asecond width that is relatively small in order to support the pelvicfloor muscles in the region while allowing for the anatomical contoursof the region at and posterior to the anal orifice 90, which cause thegluteal cleft 13 to be narrower in that region. The posterior portion ofthe intrapartum pelvic floor support device 1028, which is placedposterior to the anal orifice 90, may resume a width that is larger thanthe second width. In an embodiment, the posterior portion may have thefirst width as well, or alternatively may have a smaller or larger widththan the first width while still remaining greater than the secondwidth.

FIG. 34D illustrates an alternative embodiment of the intrapartum pelvicfloor support device 1028. In FIG. 34D, the lateral width of the centralcompression element 1034 varies along the length of the intrapartumpelvic floor support device 1028, resembling a V-shape as an example.For example, the anterior portion of the intrapartum pelvic floorsupport device 1028 that is placed near the vaginal opening 11 (theportion of the device in FIG. 34D facing the top of the page) may have afirst width that is relatively large in order to support the pelvicfloor muscles in that region. As the central compression element 1034continues down along midline axis of the patient 10, the width of thecentral compression element 1034 gradually decreases towards a commonpoint at the posterior portion of the device. As a result, a width ofthe anterior portion of the central compression element 1034 is greaterthan a width of the posterior portion of the central compression element1034.

FIG. 35 illustrates an intrapartum pelvic floor support device 1036positioned on a patient 10 according to an embodiment of the presentdisclosure. The intrapartum pelvic floor support device 1036 includesanchor pads 1038, 1040 on lateral sides of buttocks 14, 15 respectively,for example near the crowns of the buttocks 14, 15 on skin superficialor superior to the gluteus maximus muscles 89. The anchor pads 1038,1040 may be attached to the skin of the patient 10 by way of anadhesive, as discussed with respect to other embodiments above. Forexample, the adhesive may be a skin-friendly, rubber based adhesive.

The intrapartum pelvic floor support device 1036 also includes a tissueretention strap 1042 that is releasably connected laterally to eachanchor pad 1038, 1040. The tissue retention strap 1042 may beconstructed of a flexible material. Further, the tissue retention strap1042 may be formed of inner and outer portions, where the outer portionis formed of a polyurethane material and the inner portion is formed ofa nylon material. The tissue retention strap 1042 may have sufficientelasticity that it stretches before the anchor pads 1038, 1040 begindetaching from the patient 10's skin at the buttocks 14, 15. As shown,the tissue retention strap 1042 extends laterally from buttock 14 tobuttock 15. In an embodiment, the tissue retention strap 1042 extendslaterally between the buttocks 14, 15 over the anal orifice 90, whilestill allowing access to the vaginal opening 11. The length of thetissue retention strap 1042 is sufficient to extend from the anchor pad1038 to the anchor pad 1040, while a width of the tissue retention strap1042 is less than the length. In an alternative embodiment, the tissueretention strap 1042, anchor pad 1038, and anchor pad 1040 may beintegrally formed together, for example from the same material. Theintrapartum pelvic floor support device 1036 may have a shape asillustrated in FIG. 35, or alternatively may have a dumbbell shape suchas illustrated in FIG. 34C with the narrow portion extending over thepelvic floor region and the wide portions serving as the anchor pads. Inthis alternative embodiment, the intrapartum pelvic floor support device1036 may be applied to patient 10 by adhering one anchor region (e.g.,corresponding to where anchor pad 1038 was) to a lateral side of abuttock, e.g. buttock 14, pulling the strap portion of the intrapartumpelvic floor support device 1036 toward the other buttock's lateral sideto a desired tautness while also pressing the tissue of the buttock 15toward the buttock 14, and adhering the second anchor region to alateral side of the second buttock 15.

In place, the tissue retention strap 1042 is connected to each of theanchor pads 1038, 1040 with sufficient tension that it pulls thebuttocks 14, 15 toward each other. The tissue retention strap 1042 maybe connected to the anchor pads 1040, 1042 with adhesive, hook and loopsystem, or other type of fastener. The pulling of the buttocks 14, 15toward each other results in compression of the pelvic floor muscles andprevention of movement therefrom, providing pelvic floor support.

FIG. 36 illustrates an intrapartum pelvic floor support device 1044positioned on a patient 10 according to an embodiment of the presentdisclosure. In an embodiment, the intrapartum pelvic floor supportdevice 1044 is a variant of the intrapartum pelvic floor support device1036 discussed above with respect to FIG. 35 and operates to similarresults. The intrapartum pelvic floor support device 1044 includesanchor pads 1046, 1048 and curved component 1050. The curved component1050 is connected to the anchor pad 1046 by way of tissue retentionstrap 1045 and to the anchor pad 1048 by way of tissue retention strap1047. The curved component 1050 has an arcuate shape that curves awayfrom the vaginal opening 11 (e.g., a boomerang shape with ends pointingup toward the anterior of the patient 10 and a central portion extendingdown toward the posterior of the patient 10). The arcuate shape of thecurved component 1050 provides greater access to the pelvic area of thepatient 10 during childbirth. Although illustrated as extendingposterior to the anal orifice 90, the curved component 1050 may belocated across different regions over the pelvic floor area that leavesthe central portion posterior to the vaginal opening 11, for examplesuch that the central portion extends over the anal orifice 90.

In an embodiment, the curved component 1050 is composed of a relativelysolid component, such as a type of plastic or metal. The tissueretention straps 1045, 1047 may be composed of one or more materials asdiscussed above with respect to the tissue retention strap 1042 of FIG.35 above. The intrapartum pelvic floor support device 1044 providespelvic floor support by pulling the buttocks 14, 15 together to compresstissues of the pelvic floor. For example, proximal ends of the tissueretention straps 1045, 1047 (e.g., proximal to the midline of thepatient 10) may be releasably or permanently connected to lateral endsof the curved component 1050 as illustrated in FIG. 36. The distal endsof the tissue retention straps 1045, 1047 may be pulled to a desiredtightness and releasably connected to the respective anchor pads 1046,1048. The amount of pressure applied to tissues of the pelvic floor maybe varied based upon the level of tightness achieved by placement of oneor both of the tissue retention straps 1045, 1047.

In an alternative embodiment not shown in FIG. 36, the curved component1050 and tissue retention straps 1045, 1047 may be replaced by a singletissue retention strap that has a laterally pre-contoured shape thatalso results in an arcuate shape to provide increased access to thepelvic area. In such an embodiment, the single tissue retention strapmay be composed of a material with sufficient firmness to retain itsarcuate shape in the anterior-posterior direction under stress whilestill retaining sufficient flexibility in the lateral direction toprevent tearing or breaking of the strap. This may be accomplished, forexample, by a plastic mesh with sufficient flexibility in the lateraldirection and firmness in the anterior-posterior direction. In anotheralternative embodiment, the curved component 1050, tissue retentionstraps 1045, 1047, anchor pad 1046, and anchor pad 1048 may beintegrally formed together, for example from the same material. In thisalternative embodiment, the intrapartum pelvic floor support device 1044may be applied to patient 10 by adhering one anchor region (e.g.,corresponding to where anchor pad 1046 was) to a lateral side of abuttock, e.g. buttock 14, pulling the strap portion of the intrapartumpelvic floor support device 1044 toward the other buttock's lateral sideto a desired tautness while also pressing the tissue of the buttock 15toward the buttock 14, and adhering the second anchor region to alateral side of the second buttock 15.

FIG. 37A illustrates an intrapartum pelvic floor or anococcygeal supportdevice 1052 positioned on a patient 10 according to an embodiment of thepresent disclosure. The intrapartum pelvic floor support device 1052includes a contoured support 1054 and straps 1056, 1058. In anembodiment, the contoured support 1054 is an inflatable contouredsupport, for example using some form of fluid such as air or liquid asthe inflation medium. Where the contoured support 1054 is inflatable, itmay be partially inflatable (e.g., a portion of the contoured support1054 comes pre-inflated or is composed of a more solid material aroundwhich the rest of the contoured support 1054 is inflated) orsubstantially fully inflatable (e.g., the contoured support 1054 hassubstantially no fluid within it prior to first use). The contouredsupport 1054 may be contoured to the general shape of the buttocks 14,15 as well as the gluteal cleft 13 therebetween at a posterior area ofthe patient 10.

In the pictured embodiment, the contoured support 1054 is held in placeagainst the patient 10 by way of the straps 1056, 1058, which are placedlaterally to the crowns of the buttocks 14, 15. The contoured support1054 may be connected to the straps 1056, 1058 with an adhesive or hookand loop system, as described with respect to other embodiments above.Alternatively, the straps 1056, 1058 may be releasably inserted throughslots in the contoured support 1054. As another alternative, the straps1054, 1056 may be permanently connected to the contoured support 1054,e.g., formed with the contoured support 1054. As will be recognized,where adhesives are used, the straps 1056, 1058 may alternatively beanchor pads as described in other previous embodiments. Each of straps1056, 1058 may be releasably connectable. For example, each strap 1056,1058 may have a hook and loop system that enables the circumferentialsize of the straps to be larger or smaller while closed to accommodatevarying leg sizes. In an alternative embodiment, the straps 1056, 1058may use a buckle to be adaptively sized to the particular size of agiven patient 10. In another alternative embodiment, the straps 1056,1058 may use a ratchet-type system with a spring-loaded finger on areceiving end of the straps and corresponding teeth on an inserting endof the straps so that the straps may adaptively sized to the given sizeof a given patient 10. The straps 1056, 1058 may be attached to thepatient 10 at the thighs of the patient 10, for example close to thepelvic region as illustrated in FIG. 37A.

After application to a patient 10, the intrapartum pelvic floor supportdevice 1052 may be inflated as much as desired to provide pelvic floorsupport. The intrapartum pelvic floor support device 1052 providespelvic floor and/or anococcygeal support by cradling the buttocks 14, 15and laterally compressing the tissue between the buttocks, including thepelvic floor muscles, together. The compression may prevent one or morepelvic floor muscles from trauma such as may result from overstretching,tissue distension, or other strain during childbirth. After the initialplacement and inflation on the patient 10, the contoured support 1054may be further inflated or deflated to increase or decrease,respectively, the amount of compression on one or more tissuesassociated with the pelvic floor.

FIGS. 37B and 37C illustrate alternative embodiments of the intrapartumpelvic floor support device 1052. As illustrated in FIG. 37B, instead ofthe contoured support 1054 extending across only a posterior portion orouter buttock region of the patient 10, the contoured support 1054′ ofthe intrapartum pelvic floor support device 1052′ also includes asupport structure 1053 that extends from the lateral flanks 18, 19inward toward the gluteal cleft 13, covering the anal orifice 90 andtissues superior to the pelvic floor (e.g., the skin overlying thepelvic floor). The support structure 1053 may also be inflatableaccording to one or more of the embodiments discussed above with respectto FIG. 37A. The inner surface of the support structure 1053 may beconcave to approximately follow the contour of the buttocks 14, 15, andthe gluteal cleft 13. The material of the support structure 1053 may bepre-formed with the concave structure. In addition or in thealternative, the inner material may also be more flexible than the outermaterial of the contoured support 1054 such that, when inflated, thematerial of the inner surface of the support structure 1053 may adapt inshape to accommodate the contours of the buttocks 14, 15, and thegluteal cleft.

FIGS. 37C-37E illustrate another alternative embodiment to that of FIGS.37A and 37B. FIG. 37C illustrates a bottom view of an intrapartum pelvicfloor support device 1053″, FIG. 37D illustrates a perspective view ofan intrapartum pelvic floor support device 1053″, and FIG. 37Eillustrates a side view of an intrapartum pelvic floor support device1053″. As illustrated in 37C, the intrapartum pelvic floor supportdevice 1052″ includes a support structure 1053″. Unlike the supportstructure 1053 depicted in FIG. 37B, however, the support structure1053″ includes a recess 1055 that exposes the anal orifice 90.

FIG. 38 illustrates an intrapartum pelvic floor support device 1060positioned on a patient 10 according to an embodiment of the presentdisclosure. The intrapartum pelvic floor support device 1060 includes asupport base 1061 and lateral supports 1062, 1064. In an embodiment, thelateral supports 1062, 1064 are physically joined to the support base1061, for example by way of one or more connectors or adhesive. Inanother embodiment, the lateral supports 1062, 1064 are formed with thesupport base 1061 together, for example by injection molding. Theintrapartum pelvic floor support device 1060 may be placed at aposterior region of the patient 10, as shown in FIG. 38, for examplenear the coccyx.

The support base 1061 may be composed of a polymer, a metal, or otherfirm material capable of providing an opposing lateral force to thatexerted on the lateral supports 1062, 1064 when applied during theintrapartum period. The intrapartum pelvic floor support device 1060 maybe attached to a patient bed for additional lateral support.Alternatively, the intrapartum pelvic floor support device 1060 may beincorporated into a platform that the patient 10 lies on, such as on abed or some other underlying support. In another alternative embodiment,the intrapartum pelvic floor support device 1060 may be made to resemblea pillow that the patient 10 lies on.

The lateral supports 1062, 1064 may be releasably connected to thesupport base 1061 in order to enable repositioning of the intrapartumpelvic floor support device 1060 to provide more or less support to thepatient 10's pelvic floor as desired. As one example, the lateralsupports 1062, 1064 may be attached to a track that is placed within agroove in the surface of the support base 1061 that faces/contacts thepatient 10. The lateral supports 1062, 1064 may be able to slide alongthis track in a reciprocal fashion, e.g. applying sliding pressure tothe lateral support 1062 to move it laterally towards the gluteal cleft13 of the patient 10 causes a corresponding lateral move of the lateralsupport 1064 close to the gluteal cleft 13, and vice versa. In thisembodiment, once the lateral supports 1062, 1064 have been moved to adesired position, they may be locked by any suitable locking mechanismas will be recognized by those skilled in the relevant art(s). Asanother example, the support base 1061 may include a plurality of holesor pegs spaced along its upper surface. Each of the lateral supports1062, 1064 may have corresponding pegs or holes, respectively, toreleasably join with the support base 1061 at different lengths from oneanother.

The support base 1061 operates together with the lateral supports 1062,1064 in order to provide pressure laterally to the buttocks 14, 15, forexample at locations extending from near the crowns of the buttocks 14,15 toward the flanks 18, 19. In an embodiment, the lateral supports1062, 1064 may extend from the crowns of the patient 10's hips where thereference numbers 18 and 19 point to near the crowns of the buttocks 14,15. The lateral supports 1062, 1064 may alternatively extend from nearthe crowns of the buttocks 14, 15 toward a location midway between thepatient 10's crowns of the hips. This applies lateral pressure tocompress the buttocks 14, 15 together, resulting in pressure beingapplied to one or more tissues of the pelvic floor, thereby supportingthe pelvic floor during the intrapartum period.

FIG. 39 illustrates an intrapartum pelvic floor support device 1066positioned on a patient 10 according to an embodiment of the presentdisclosure. The intrapartum pelvic floor support device 1066 includes asupport device 1068, anchor pads 1069, 1070, and retention straps 1072,1074. The support device 1068 may be connected to the anchor pads 1069,1070 via the retention straps 1072, 1074 respectively. The anchor pads1069, 1070 may be attached to the skin of the patient 10 laterally nearthe crowns of the buttocks 14, 15 by way of an adhesive, such asdiscussed with respect to other embodiments above. For example, theadhesive may be a skin-friendly, rubber based adhesive. The retentionstraps 1072, 1074 may connect with one or both of the support device1068 and the anchor pads 1069, 1070 with an adhesive or hook and loopsystem, as described with respect to other embodiments above to namejust a few examples. Where the retention straps 1072, 1074 connect withjust one of either the anchor pads or the support device, the retentionstraps may be formed with the other. For example, in an embodiment theretention straps 1072, 1074 may be formed as part of the anchor pads1069, 1070 as regions not adhered to the skin of the patient 10. In suchan embodiment, the retention straps 1072, 1074 are releasably connectedwith the support device 1068 while being an integral part of the anchorpads 1069, 1070. In another alternative embodiment, the support device1068, retention straps 1072, 1074, anchor pad 1069, and anchor pad 1070may be integrally formed together, for example from the same material.In this alternative embodiment, the intrapartum pelvic floor supportdevice 1066 may be applied to patient 10 by adhering one anchor region(e.g., corresponding to where anchor pad 1069 was) to a lateral side ofa buttock, e.g. buttock 14, pulling the support device 1068 of theintrapartum pelvic floor support device 1066 toward the other buttock'slateral side to a desired tautness while also pressing the tissue of thebuttock 15 toward the buttock 14, and adhering the second anchor regionto a lateral side of the second buttock 15.

The support device 1068 may be contoured to the anatomy of the patient10. For example, the central portion of the support device 1068 maycontour to the gluteal cleft 13 of the patient 10 and include concaveinner surfaces extending out laterally in order to receive the buttocks14, 15 and generally fit their contour. The support device 1068 mayextend out in the anterior direction as well, with side edges of thesupport device 1068 extending beyond the beginning of the vaginalopening 11 while the central portion of the support device 1068 extendsin the anterior direction to stop before the vaginal opening 11, therebycovering at least a portion of the perineum as illustrated in FIG. 39.In an embodiment, the support device 1068 may have varying levels ofrigidity throughout the device. For example, the central portion of thesupport device 1068 may be rigid and become less rigid as the supportdevice 1068 extends out laterally from the central portion. This mayresult in the lateral components of the support device 1068 being morecomplaint to contour to the shape of the patient 10's buttocks 14, 15when applied to the patient 10. For example, the support device 1068 mayhave increased rigidity at the central portion, e.g. focused at an areaat and/or near the anal sphincter 86 with increased flexibility closerto the perineum of the patient 10 and as the support device 1068 extendslaterally away from the central portion.

Further, the configuration of the central portion may be designed so asto provide different levels of pressure to the tissue it comes incontact with. In one example, the central portion of the support device1068 may have a ridge that fits within the gluteal cleft 13 andapproximately uniformly comes into contact with the pelvic floor tissueextending from the support device 1068's anterior portion to itsposterior portion. The ridge may have a uniform height to apply uniformpressure along the cleft, or alternatively may have an increase ordecrease in height in one or more areas to provide more or lesspressure, respectively, at those points. In an alternative embodiment,the central portion may have two parallel ridges and a small valleytherebetween that runs along the length from the anterior to posteriorportions of the patient 10, such as discussed above with respect to FIG.34B.

In an alternative embodiment, the lateral components of the supportdevice 1068, and/or the placement/size of the anchor pads 1069, 1070 arelarge enough that lateral edges of the support device 1068 mayreleasably attach directly to the anchor pads 1069, 1070. In thisembodiment, there is little need for the retention straps 1072, 1074 andmay be omitted. The lateral edges may releasably attach using a hook andloop system or adhesive, to name some examples.

In place, the support device 1068 may cover several muscles of thepelvic floor, for example at least a portion of the bulbocaervnosusmuscles 80, at least a portion of the ischiocavernosus muscles 82, thetransverse perineal muscles 84, the external anal sphincter muscle 86,and the levator ani muscle 88, thereby providing pelvic floor support.As illustrated, the intrapartum pelvic floor support device 1066 mayprovide this support and/or pressure without interfering with thebirthing canal or vaginal opening 11. In this manner, the intrapartumpelvic floor support device 1066 may non-invasively reduce and/orinhibit pelvic floor trauma.

FIGS. 40 and 41 illustrate an intrapartum pelvic floor support device1076 according to an embodiment of the present disclosure. Theintrapartum pelvic floor support device 1076 includes thin sheet 1078,anterior mesh 1080, optional hole 1082, lateral support meshes 1084 and1086, and central support mesh 1088. The thin sheet 1078 may be a thinfilm of plastic that is flexible enough to conform to the anatomy of thepatient 10. In an embodiment, the thin sheet 1078 may be composed of amedical grade plastic. The thin sheet 1078 may have adhesive throughoutits top side in order to adhere to the skin of the patient 10. The thinsheet 1078 may extend from an anterior portion 1090 that reaches theperineum area adjacent to the vaginal opening 11 in a posteriordirection to the posterior portion 1091 that may curve around the coccyxand extend upward the back of the patient 10, for example near or at theS3 or S4 vertebrae. Further, the thin film 1078 extends between lateralsupport meshes 1086 and 1084.

The intrapartum pelvic floor support device 1076's anterior mesh 1080 issized and shaped so as to cover and support the pelvic floor of thepatient 10. As shown in FIGS. 40 and 41, the anterior mesh 1080 coversthe tissues of the perineum and extends in the posterior direction overthe anus and onward, curving upward with the curve of the gluteal cleft13. The anterior mesh 1080 may include, for example, an interwovennetwork of fibers or rods that are flexible in one direction but morerigid in another. The anterior mesh 1080 is connected to the lateralsupport meshes 1084, 1086 as well as the central support mesh 1088. Theanterior mesh 1080 transfers the load applied to it from the tissues ofthe pelvic floor to the lateral support meshes 1084, 1086 and thecentral support mesh 1088. In an embodiment, the anterior mesh 1080,lateral support meshes 1084, 1086 and central support mesh 1088 arethicker than the thin sheet 1078 in order to provide support to thepelvic floor. In an embodiment, the stiffness of the anterior mesh 1080may be three to four times stiffer than that of the lateral supportmeshes 1084, 1086 and the central support mesh 1088. As shown in FIGS.40-41, the anterior support mesh 1080 may have an optional hole 1082that lies generally over the region of the anal orifice 90. The optionalhole 1082 may be, for example, a section of the anterior support mesh1080 that has a circular perforation. As a result, if desired theperforated area of the anterior mesh 1080 may be removed before or afterthe intrapartum pelvic floor support device 1076 has been applied to thepatient 10.

Adhesive may have been applied previously to the entirety of the side ofthe intrapartum pelvic floor support device 1076 that is attached to thepatient 10. Alternatively, adhesive may be applied to the intrapartumpelvic floor support device 1076 or to the patient 10 immediately priorto the intrapartum pelvic floor support device 1076 being temporarilyattached to the patient 10. Where the intrapartum pelvic floor supportdevice 1076 has adhesive previously applied, the intrapartum pelvicfloor support device 1076 may include three separate sheets of backingon the side that has the adhesive. In order to apply the intrapartumpelvic floor support device 1076 to the patient 10, a person may firstremove the backing (or apply adhesive in alternative embodiments) andthen either have the patient 10 sit on the intrapartum pelvic floorsupport device 1076 on the exposed adhesive side, or apply to thepatient 10 while the patient 10 is in a sitting/squatting/reclinedposition. This may include manually assisting the portion of the deviceincluding the anterior support mesh 1080 and/or the central support mesh1088 to adequately match the contour of the patient 10, such as enteringthe gluteal cleft 13 and following the contour of the buttocks 14, 15.The intrapartum pelvic floor support device 1076 is positioned on thepatient 10 so that the anterior mesh 1080 of the anterior portion 1090is located near the vaginal opening 11 and extending from there inposterior and lateral directions.

In an alternative embodiment, instead of the thin sheet 1078 and themeshes 1080, 1084, 1086, and 1088, the intrapartum pelvic floor supportdevice 1076 may be composed of a single device, such as one that hasbeen injection molded. In this embodiment, the intrapartum pelvic floorsupport device 1076 may include ribbing with a variety of differentstrengths throughout the surface of the device. For example, there maybe ribbing throughout but the ribbing where the anterior support mesh1080 would otherwise be is thicker and/or otherwise stronger than otherregions where the FIGS. 40, 41 do not show any mesh. In anotheralternative embodiment, the thin sheet 1078 is not included. In thisembodiment, the adhesive would be applied to the sides of the meshes1080, 1084, 1086, and 1088 that face and attach to the patient 10.

In an embodiment, the intrapartum pelvic floor support device 1076 mayalso include one or more sensors designed to detect stretching of theintrapartum pelvic floor support device 1076. This stretching may becorrelated to a condition of one or more muscles of the pelvic floor.Further, the different rods or fibers of the meshes 1080, 1084, 1086,and 1088 may be color fibers that change colors based on the level ofstretching they undergo. This color change may be correlated to anamount of stretching the underlying muscles have undergone, a level ofstress the muscles of the pelvic floor may have experienced, or feedbackto indicate whether more or less strain should be applied duringchildbirth without causing pelvic floor trauma.

The foregoing outlines features of several embodiments so that thoseskilled in the art may better understand the aspects of the presentdisclosure. Those skilled in the art should appreciate that they mayreadily use the present disclosure as a basis for designing or modifyingother processes and structures for carrying out the same purposes and/orachieving the same advantages of the embodiments introduced herein.Those skilled in the art should also realize that such equivalentconstructions do not depart from the spirit and scope of the presentdisclosure, and that they may make various changes, substitutions andalterations herein without departing from the spirit and scope of thepresent disclosure. Furthermore, although elements of the describedembodiments may be described or claimed in the singular, the plural iscontemplated unless limitation to the singular is explicitly stated.Additionally, all or a portion of any aspect and/or embodiment may beutilized with all or a portion of any other aspect and/or embodiment.

What is claimed is:
 1. A non-invasive intrapartum pelvic floor supportdevice, comprising: a central support element having a convex contactsurface configured to be held against and extend from an anteriorportion posterior to a vaginal opening of a patient to a posteriorportion of the patient that is posterior to an anal orifice of thepatient, said central support element having sufficient rigidity toapply force to tissue superficial to a pelvic floor of the patient, saidconvex contact surface being dimensioned and anatomically configured tospan across and cover the anal orifice of said patient without enteringan anal canal and to not substantially interfere with a birthing canalof the patient during childbirth; a first compression element extendingfrom the central support element in a first lateral direction, the firstcompression element comprising a first surface configured to flexiblyfollow at least part of a first contour of a first buttock of thepatient when the first compression element is applied to the patient;and a second compression element extending from the central supportelement in a second lateral direction opposite to the first lateraldirection, the second compression element comprising a second surfaceconfigured to flexibly follow at least part of a second contour of asecond buttock of the patient when the second compression element isapplied to the patient, wherein the rigidity of the intrapartum pelvicfloor support device varies gradually from the central support elementlaterally outwardly along said compression elements, and wherein thenon-invasive intrapartum pelvic floor support device is configured to beheld against said tissue superficial to said pelvic floor of the patientto support the pelvic floor during an intrapartum period of the patient.2. The non-invasive intrapartum pelvic floor support device of claim 1,wherein the central support element comprises a midline, the firstcompression element extending from the midline in the first lateraldirection and the second compression element extending from the midlinein the second lateral direction, and wherein the variation in rigidityis effected by the material thinning laterally outwardly from saidmidline toward lateral edges of the first and second compressionelements.
 3. The non-invasive intrapartum pelvic floor support device ofclaim 1, wherein the first and second compression elements comprise afirst width proximate to the anterior portion and a second widthproximate to the posterior portion, the second width being larger thanthe first width.
 4. The non-invasive intrapartum pelvic floor supportdevice of claim 1, wherein the pelvic floor support device is sterile.5. The non-invasive intrapartum pelvic floor support device of claim 1,further comprising: a first adhesive coating on the first surface of thefirst compression element; and a second adhesive coating on the secondsurface of the second compression element.
 6. The non-invasiveintrapartum pelvic floor support device of claim 5, wherein: at least aportion of the first surface comprising the first adhesive coating isconfigured to releasably attach to the first buttock; and at least aportion of the second surface comprising the second adhesive coating isconfigured to releasably attach to the second buttock.
 7. Thenon-invasive intrapartum pelvic floor support device of claim 1, furthercomprising a pair of extending securing members attached respectively tosaid first and second compression elements, said pair of extendingsecuring members being configured to assist in holding the intrapartumpelvic floor support device in pressurized engagement against tissuesuperficial to the pelvic floor of the patient.
 8. A non-invasiveintrapartum pelvic floor support device, comprising: a convex centralcontact surface dimensioned and anatomically configured to extendlongitudinally between an anterior portion and a posterior portion ofsaid device along a midline axis only from an anterior portion posteriorto a vaginal opening of a patient to a posterior portion of the patientthat is posterior to an anal orifice of the patient to thereby spanacross and cover the anal orifice of said patient without entering ananal canal and to not substantially interfere with a birthing canal ofthe patient during childbirth; a first compression element extendingfrom the midline axis in a first lateral direction, the firstcompression element comprising a first concave surface configured toflexibly follow at least part of a first contour of a first buttockwithin a gluteal cleft of the patient when applied to the patient; and asecond compression element extending from the midline axis in a secondlateral direction different from the first lateral direction, the secondcompression element comprising a second concave surface configured toflexibly follow at least part of a second contour of a second buttockwithin the gluteal cleft of the patient when applied to the patient,wherein the non-invasive intrapartum pelvic floor support device isconfigured to be held against tissue superficial to a pelvic floor ofthe patient to support the pelvic floor during an intrapartum period ofthe patient.
 9. The non-invasive intrapartum pelvic floor support deviceof claim 8, wherein the central contact surface is configured to followat least part of a third contour of a sagittal plane of the patienttoward a coccyx of the patient when applied to the patient.
 10. Thenon-invasive intrapartum pelvic floor support device of claim 8, whereinthe first and second compression elements comprise a first widthproximate to the anterior portion and a second width proximate to theposterior portion, the second width being larger than the first width.11. The non-invasive intrapartum pelvic floor support device of claim 8,wherein the first and second compression elements extend integrally fromsaid convex central contact surface.
 12. The non-invasive intrapartumpelvic floor support device of claim 8, further comprising: a firstadhesive coating on a first surface of the first compression element;and a second adhesive coating on a second surface of the secondcompression element.
 13. The non-invasive intrapartum pelvic floorsupport device of claim 12, wherein: at least a portion of the firstsurface comprising the first adhesive coating is configured toreleasably attach to the first buttock; and at least a portion of thesecond surface comprising the second adhesive coating is configured toreleasably attach to the second buttock.
 14. A non-invasive intrapartumpelvic floor support device, comprising: a convex central contactsurface dimensioned and anatomically configured to extend along amidline axis only from an anterior portion posterior to a vaginalopening of a patient to a posterior portion of the patient that isposterior to an anal orifice of the patient to thereby span across andcover the anal orifice of said patient without entering an anal canaland to not substantially interfere with a birthing canal of the patientduring childbirth; a first compression element extending from themidline axis in a first lateral direction, the first compression elementcomprising a first concave surface configured to flexibly follow atleast part of a first contour of a first buttock within a gluteal cleftof the patient when applied to the patient; and a second compressionelement extending from the midline axis in a second lateral directiondifferent from the first lateral direction, the second compressionelement comprising a second concave surface configured to flexiblyfollow at least part of a second contour of a second buttock within thegluteal cleft of the patient when applied to the patient, wherein thenon-invasive intrapartum pelvic floor support device is configured to beheld against tissue superficial to a pelvic floor of the patient tosupport the pelvic floor during an intrapartum period of the patient andwherein said convex central contact surface has sufficient rigidity toapply force to said tissue superficial to said pelvic floor of thepatient.